Cresolphthalein Complexone, Calcium

FDA product code CIC · 99 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1145
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-29 – 2013-05-02

CIC 2013-05-02

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)

Applicant Hitachi Chemical Diagnostics, Inc.

K number K130870

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CIC 2009-03-09

DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K083339

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CIC 2007-04-26

ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H

Applicant Horiba Abx

K number K070249

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CIC 2006-03-24

SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS

Applicant Arkray, Inc.

K number K053401

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CIC 2005-02-15

SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS

Applicant Arkray, Inc.

K number K050077

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CIC 2004-06-25

RAICHEM CALCIUM (OCPC) LIQUID REAGENT

Applicant Hemagen Diagnostics, Inc.

K number K041009

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CIC 2003-03-13

ATAC CALCIUM REAGENT AND ATAC CALIBRATOR

Applicant Elan Diagnostics

K number K023105

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CIC 2001-12-21

WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002

Applicant Wiener Laboratories Saic

K number K013652

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CIC 2000-04-05

RANDOX CALCIUM

Applicant Randox Laboratories, Ltd.

K number K000375

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CIC 1999-05-25

BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02

Applicant A.P. Total Care, Inc.

K number K991111

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CIC 1997-06-24

CALCIUM REAGENT

Applicant Carolina Liquid Chemistries Corp.

K number K971907

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CIC 1996-10-31

COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS

Applicant Roche Diagnostic Systems, Inc.

K number K963292

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CIC 1996-03-13

CALCIUM REAGENT

Applicant Derma Media Lab., Inc.

K number K955939

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CIC 1995-01-05

CALCIUM REAGENT

Applicant Olympus America, Inc.

K number K944258

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CIC 1994-02-01

IL TEST CALCIUM

Applicant Instrumentation Laboratory CO

K number K931362

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CIC 1993-09-27

CALCIUM TEST ITEM NUMBER 65409

Applicant Em Diagnostic Systems, Inc.

K number K932158

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CIC 1992-10-19

OLYMPUS CALCIUM REAGENT

Applicant Olympus Corp.

K number K924435

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CIC 1992-09-15

MILES URINE CALCIUM METHOD

Applicant Heraeus Kulzer, Inc.

K number K923034

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CIC 1992-07-10

OLYMPUS CALCIUM REAGENT

Applicant Olympus Corp.

K number K922233

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CIC 1992-05-13

CALCIUM-ARSENAZO III REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K921625

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CIC 1992-01-30

CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL

Applicant Enzyme Technology, Inc.

K number K912027

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CIC 1991-01-15

SYSTEMATE CALCIUM (EPOS APPLICATION) #65409

Applicant Em Diagnostic Systems, Inc.

K number K905659

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CIC 1990-10-04

SYNERMED CALCIUM REAGENT KIT

Applicant Synermed, Inc.

K number K903233

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CIC 1990-09-13

CALCIUM ARSENAZO III REAGENT

Applicant Trace Scientific , Ltd.

K number K903896

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CIC 1990-08-17

COBAS READY CALCIUM REAGENT

Applicant Roche Diagnostic Systems, Inc.

K number K896224

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CIC 1990-07-17

CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432

Applicant Amresco, Inc.

K number K902479

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CIC 1990-04-19

CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)

Applicant Technicon Instruments Corp.

K number K901226

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CIC 1989-09-25

ABBOTT SPECTRUM(R) CALCIUM REAGENT

Applicant Abbott Laboratories

K number K894407

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CIC 1989-09-05

CALCIUM TEST ITEM NUMBER: 65409

Applicant Em Diagnostic Systems, Inc.

K number K893778

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CIC 1989-05-03

IQ CALCIUM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K891217

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CIC 1989-01-27

TECHNICON RA-100 SYSTEM CALCIUM METHOD

Applicant Technicon Instruments Corp.

K number K884599

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CIC 1989-01-13

CALCIUM TEST ITEM NUMBER: SR1009

Applicant Em Diagnostic Systems, Inc.

K number K884986

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CIC 1988-11-29

BIOTROL BILIRUBIN MONOREACTIF

Applicant Biotrol, USA, Inc.

K number K884480

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CIC 1988-11-29

TECHNICON ASSIST(R) CALCIUM METHOD

Applicant Technicon Instruments Corp.

K number K884433

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CIC 1988-08-08

A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM

Applicant A-Kem, Inc.

K number K882586

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CIC 1988-05-27

CALCIUM

Applicant Catachem, Inc.

K number K880308

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CIC 1988-04-18

CALCIUM, CATALOGUE NUMBER 122-20

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K881054

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CIC 1988-04-05

CALCIUM REAGENT SET

Applicant Tech-Neal Scientific, Inc.

K number K880845

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CIC 1988-02-11

CALCIUM ASSAY KIT, NUMBER 120-19

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K874496

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CIC 1987-12-14

PARAMAX CALCIUM REAGENT

Applicant Baxter Healthcare Corp

K number K873519

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CIC 1987-12-04

CRESOLPHTHALEIN COMPLEXONE, CALCIUM

Applicant Pointe Scientific, Inc.,

K number K874131

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CIC 1987-10-02

MULTICHEM CALCIUM S0910

Applicant Simmler, Inc.

K number K873697

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CIC 1987-10-02

WAKO(TM) AUTOKIT CALCIUM

Applicant Wako Chemicals USA, Inc.

K number K873334

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CIC 1987-08-21

CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD

Applicant Trace Scientific , Ltd.

K number K870362

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CIC 1987-08-18

SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)

Applicant Boehringer Mannheim Corp.

K number K872306

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CIC 1987-06-12

SIGMA'S CALCIUM PROCEDURE NO. 587

Applicant Sigma Diagnostics, Inc.

K number K871152

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CIC 1987-05-26

SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)

Applicant Boehringer Mannheim Corp.

K number K871811

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CIC 1987-04-29

CALCIUM TEST

Applicant Sclavo, Inc.

K number K870629

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CIC 1987-03-06

EASY-TEST CALCIUM (CA), ITEM NO. 67528/93

Applicant Em Diagnostic Systems, Inc.

K number K870170

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CIC 1987-02-04

UNIFAST CALCIUM TEST

Applicant Sclavo, Inc.

K number K864661

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CIC 1987-01-09

CRESOLPHTHALEIN COMPLEXONE, CALCIUM

Applicant Tech-Co, Inc.

K number K864741

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CIC 1986-11-13

VISION (TM) CALCIUM

Applicant Abbott Laboratories

K number K863670

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CIC 1986-09-26

CALCIUM PROCEDURE

Applicant Data Medical Associates, Inc.

K number K863256

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CIC 1986-09-16

EMDS(TM) CALCIUM TESTPACKS, #67687/95

Applicant Em Diagnostic Systems, Inc.

K number K863003

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CIC 1986-07-29

ANALYST ANALYTICAL TEST ROTORS

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K862274

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CIC 1986-06-27

CRESOLPHTHALEIN COMPLEXONE, CALCIUM

Applicant Amresco, Inc.

K number K860664

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CIC 1986-05-29

CALCIUM PROCEDURE

Applicant Data Medical Associates, Inc.

K number K861657

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CIC 1986-04-03

A-GENT LIQUID CALCIUM

Applicant Abbott Laboratories

K number K860425

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CIC 1986-02-11

CALCIUM (CPC) REAGENT SET

Applicant Sterling Diagnostics, Inc.

K number K860044

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CIC 1986-01-22

CALCIUM LIQUID STABLE REAGENT SET

Applicant Medical Analysis Systems, Inc.

K number K855041

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CIC 1986-01-07

NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909

Applicant Nobel Scientific Industries, Inc.

K number K854716

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CIC 1985-08-02

CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ

Applicant Simmler, Inc.

K number K853050

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CIC 1985-07-15

AMRESCO CALCIUM REAGENT SET

Applicant American Research Products Co.

K number K852657

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CIC 1985-06-25

CA BUFFER CA DYE

Applicant Alpkem Corp.

K number K852002

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CIC 1985-06-10

CALCIUM

Applicant Dilab, Inc.

K number K850929

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CIC 1985-02-06

CALCIUM

Applicant Boehringer Mannheim Corp.

K number K850281

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CIC 1985-01-03

TOTAL BILIRUBIN FOR DEMAND ANALYZER

Applicant Advanced Biomedical Methods, Inc.

K number K844243

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CIC 1985-01-03

CALCIUM REAGENT FOR DEMAND ANALYZER

Applicant Advanced Biomedical Methods, Inc.

K number K844241

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CIC 1984-10-30

TOTAL CALCIUM REAGENT SET

Applicant Livonia Diagnostics, Inc.

K number K843895

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CIC 1984-09-20

RAICHEM CALCIUM REAGENT

Applicant Reagents Applications, Inc.

K number K843353

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CIC 1984-08-29

SYSTEMATE CALCIUM 67214

Applicant Em Diagnostic Systems, Inc.

K number K843152

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CIC 1984-07-20

CALCIUM ASSAY KIT

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K842509

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CIC 1984-05-01

SERUM CALCIUM REAGENT SET

Applicant Medical Specialties, Inc.

K number K841051

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CIC 1984-02-21

FLOW-PAC CALCIUM REAGENT SET

Applicant American Research Products Co.

K number K834336

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CIC 1983-11-03

CALCIUM DYE REAGENT-CS-718-A/BUFFER

Applicant Fisher Scientific Co., LLC

K number K833035

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CIC 1983-10-14

PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS

Applicant American Dade

K number K832708

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CIC 1983-08-24

SANDARE CALCIUM PROCEDURE

Applicant Sandare Chemical Co., Inc.

K number K832183

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CIC 1983-02-18

ULTRA CHEM CRESOLCAVERSACHEM #65082

Applicant Emd Chemicals, Inc.

K number K830238

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CIC 1983-01-12

ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082

Applicant Em Industries, Inc.

K number K823756

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CIC 1983-01-07

COBAS REAGENT FOR CALCIUM

Applicant Hoffmann-La Roche, Inc.

K number K823577

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CIC 1982-12-03

LIQUIZYME CALCIUM REAGENT SET

Applicant American Research Products Co.

K number K823219

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CIC 1982-09-14

PSI CALCIUM REAGENT

Applicant Pointe Scientific, Inc.,

K number K822469

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CIC 1982-07-13

SERUM CALCIUM REAGENT SET

Applicant Omega Medical Electronics

K number K821196

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CIC 1982-02-12

WAKO CALCIUM C TEST

Applicant Wako Chemicals USA, Inc.

K number K820241

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CIC 1982-01-28

ASTRA-T CALCIUM REAGENT

Applicant Hi Chem, Inc.

K number K820090

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CIC 1981-10-09

TOTAL CALCIUM REAGENT SET

Applicant Anco Medical Reagents & Assoc.

K number K812835

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CIC 1981-08-13

GILCHEM CALCIUM REAGENT

Applicant Gilford Diagnostics

K number K812110

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CIC 1981-07-10

KING DIAGNOSTICS CALCIUM TEST

Applicant King Diagnostics, Inc.

K number K811748

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CIC 1980-12-19

BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY

Applicant Beckman Instruments, Inc.

K number K802923

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CIC 1980-10-10

8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.

Applicant Panmed, Inc.

K number K802164

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CIC 1980-05-28

REAGENTS FOR DETERM. CALCIUM IN HUMAN

Applicant Diagnostic Solutions, Inc.

K number K800680

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CIC 1979-12-06

DONNECT. DIAG. CALCIUM DIAG. REAGENT

Applicant Connecticut Diagnostics, Ltd.

K number K792337

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CIC 1978-07-27

CALCIUM REAGENT SYSTEM NO. 585

Applicant Sigma Chemical Co.

K number K780983

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CIC 1977-10-25

CALCIUM

Applicant Gamma Enterprises, Inc.

K number K771831

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CIC 1977-08-03

CALCIUM REAGENT

Applicant Mallinckrodt Critical Care

K number K771310

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CIC 1977-06-02

CENTRIFI CHEM CALCIUM REAGENT

Applicant Union Carbide Corp.

K number K770460

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CIC 1977-05-03

CALCIUM PROCEDURE, TEKPOINT DIRECT

Applicant Icn Pharmaceuticals, Inc.

K number K770449

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CIC 1976-11-01

TEST, REFORMULATED HYCEL HMA CALCIUM

Applicant Hycel, Inc.

K number K760468

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CIC 1976-10-29

REAGENT, CALCIUM DETERMINATION

Applicant Simmler & Son, Inc.

K number K760475

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