Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

FDA product code CJE · 124 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1050
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-26 – 2025-12-19

CJE 2025-12-19

Tru Liver Health Test Panel

Applicant Truvian Health

K number K251074

View details →

CJE 2024-10-16

Alkaline Phosphatase

Applicant Abbott Laboratories Diagnostics Division

K number K240468

View details →

CJE 2023-07-21

Alkaline Phosphatase2

Applicant Abbott Ireland Diagnostics Division

K number K223317

View details →

CJE 2019-08-30

Yumizen C1200 ALP, Yumizen C1200 Albumin

Applicant HORIBA ABX SAS

K number K191245

View details →

CJE 2018-01-25

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer

Applicant Lite-On Technology Corp. H.S.P.B.

K number K171971

View details →

CJE 2017-05-10

ALP IFCC Gen.2

Applicant Roche Diagnostics Operations (Rdo)

K number K171080

View details →

CJE 2017-04-21

Randox RX Daytona Plus Alkaline Phosphatase (ALP)

Applicant Randox Laboratories Limited

K number K162275

View details →

CJE 2013-08-15

ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT

Applicant Alfa Wassermann Diagnostic Technologies, LLC

K number K131351

View details →

CJE 2013-03-22

S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)

Applicant Hitachi Chemical Diagnostics, Inc.

K number K130141

View details →

CJE 2012-07-12

ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT

Applicant Alfa Wassermann

K number K113436

View details →

CJE 2011-12-29

ELITTECH CLINICAL SYSTEMS ALP IFCC SL

Applicant Elitechgroup

K number K113269

View details →

CJE 2011-05-20

EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS

Applicant Medica Corp.

K number K101090

View details →

CJE 2008-02-28

ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL

Applicant Thermofisher Scientific OY

K number K073191

View details →

CJE 2006-07-21

GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

Applicant Horiba Abx

K number K060205

View details →

CJE 2003-10-14

COBAS INTEGRA ALP IFCC GEN.2

Applicant Roche Diagnostics Corp.

K number K033185

View details →

CJE 2002-12-26

MODIFICATION TO ALKP

Applicant Abbott Laboratories

K number K023807

View details →

CJE 2002-01-28

WIENER LAB. ALP 405

Applicant Wiener Laboratories Saic

K number K013983

View details →

CJE 2001-10-09

TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113

Applicant Thermo Dma, Inc.

K number K012518

View details →

CJE 2001-07-20

ALKALINE PHOSPHATASE LIQUID REAGENT

Applicant Jas Diagnostics, Inc.

K number K011599

View details →

CJE 2000-11-27

ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30

Applicant Diagnostic Chemicals , Ltd.

K number K003093

View details →

CJE 2000-09-26

ATAC PAK ALP REAGENT KIT

Applicant Elan Diagnostics

K number K002285

View details →

CJE 2000-01-20

ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H

Applicant Teco Diagnostics

K number K000067

View details →

CJE 1999-09-02

ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02

Applicant A.P. Total Care, Inc.

K number K991762

View details →

CJE 1999-05-19

ELAN ALKALINE PHOSPHATE REAGENT KIT

Applicant Elan Holdings, Inc.

K number K991387

View details →

CJE 1999-01-13

CARESIDE ALKALINE PHOSPHATASE

Applicant Careside, Inc.

K number K990024

View details →

CJE 1998-08-26

ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE

Applicant Roche Diagnostic Systems, Inc.

K number K981897

View details →

CJE 1998-06-22

ALKP

Applicant Abbott Laboratories

K number K981806

View details →

CJE 1998-05-20

ALKALINE PHOSPHATASE (ALKP)

Applicant Abbott Laboratories

K number K981245

View details →

CJE 1998-02-12

ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30

Applicant Diagnostic Chemicals , Ltd.

K number K980316

View details →

CJE 1997-10-22

LIQUID ALKALINE PHOSHATASE REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K973588

View details →

CJE 1997-05-16

ALP REAGENT SET

Applicant Carolina Liquid Chemistries Corp.

K number K971463

View details →

CJE 1997-02-04

ALKALINE PHOSPHATASE

Applicant Derma Media Lab., Inc.

K number K964914

View details →

CJE 1996-02-28

ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245

Applicant Sigma Diagnostics, Inc.

K number K954840

View details →

CJE 1995-11-27

ALKALINE PHOSPHATASE REAGENT SYSTEM

Applicant Medical Diagnostic Technologies, Inc.

K number K952746

View details →

CJE 1995-08-11

ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247

Applicant Sigma Diagnostics, Inc.

K number K951584

View details →

CJE 1994-12-29

ALKALINE PHOSPHATASE (ALKP) QVET

Applicant Prisma Systems

K number K942997

View details →

CJE 1994-05-17

STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET

Applicant Stanbio Laboratory

K number K941313

View details →

CJE 1993-12-09

EMDS ALKANINE PHOSPHATASE (ALP) TEST

Applicant Em Diagnostic Systems, Inc.

K number K935182

View details →

CJE 1993-09-08

AMP ALKALINE PHOSPHATASE REAGENT KIT

Applicant Synermed, Inc.

K number K931986

View details →

CJE 1992-12-03

ALKALINE PHOSPHATASE KIT

Applicant Randox Laboratories, Ltd.

K number K923507

View details →

CJE 1992-11-18

OLYMPUS ALKALINE PHOSPHATASE REAGENT

Applicant Olympus Corp.

K number K925156

View details →

CJE 1992-11-09

EMDS ALKALINE PHOSPHATASE (ALP) TEST

Applicant Em Diagnostic Systems, Inc.

K number K924574

View details →

CJE 1992-09-28

OLYMPUS ALKALINE PHOSPHATASE REAGENT

Applicant Olympus Corp.

K number K923527

View details →

CJE 1991-11-22

ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38

Applicant Em Diagnostic Systems, Inc.

K number K913921

View details →

CJE 1991-04-12

SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483

Applicant Em Diagnostic Systems, Inc.

K number K910639

View details →

CJE 1991-02-13

KINETIC ALKALINE PHOSPHATASE DETERMINATION

Applicant Biochemical Trade, Inc.

K number K905650

View details →

CJE 1990-12-28

ALKALINE PHOSPHATASE

Applicant Amresco, Inc.

K number K905684

View details →

CJE 1990-09-27

SYNERMED ALKALINE PHOSPHATASE REAGENT KIT

Applicant Synermed, Inc.

K number K904030

View details →

CJE 1990-07-17

ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT

Applicant Roche Diagnostic Systems, Inc.

K number K902560

View details →

CJE 1990-03-01

AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781

Applicant American Research Products Co.

K number K900250

View details →

CJE 1990-02-08

COULTER ALP (ALK PHOS) REAGENT

Applicant Coulter Corp.

K number K900216

View details →

CJE 1989-10-31

SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402

Applicant Em Diagnostic Systems, Inc.

K number K895250

View details →

CJE 1989-03-24

ABBOTT CLINICAL CHEMISTRY REAGENT ALP

Applicant Abbott Laboratories

K number K890521

View details →

CJE 1988-11-10

ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651

Applicant Em Diagnostic Systems, Inc.

K number K884549

View details →

CJE 1988-07-08

BIOTROL ALKALINE PHOSPHATASE

Applicant Biotrol, USA, Inc.

K number K881742

View details →

CJE 1988-04-18

ALKALINE PHOSPHATASE REAGENT, DEA BUFF

Applicant Trace America, Inc.

K number K880796

View details →

CJE 1988-04-18

RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.

Applicant Trace America, Inc.

K number K880795

View details →

CJE 1988-03-15

ALKALINE PHOSPHATASE REAGENT SET

Applicant Tech-Neal Scientific, Inc.

K number K880307

View details →

CJE 1988-02-02

ALKALINE PHOSPHATASE CAT. # 306-22, 306-23

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K875210

View details →

CJE 1987-10-29

EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021

Applicant Em Diagnostic Systems, Inc.

K number K873635

View details →

CJE 1987-10-07

MULTICHEM ALKALINE PHOSPHATASE (S0903)

Applicant Simmler, Inc.

K number K873761

View details →

CJE 1987-10-02

WAKO(TM) AUTOKIT ALP

Applicant Wako Chemicals USA, Inc.

K number K873333

View details →

CJE 1987-09-29

ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95

Applicant Em Diagnostic Systems, Inc.

K number K873681

View details →

CJE 1987-06-22

ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.

Applicant Catachem, Inc.

K number K871543

View details →

CJE 1987-01-13

ALKALINE PHOSPHATASE

Applicant Tech-Co, Inc.

K number K864905

View details →

CJE 1986-12-04

U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST

Applicant U. S. Diagnostics, Inc.

K number K863980

View details →

CJE 1986-09-29

ALKALINE PHOSPHATASE PROCEDURE

Applicant Data Medical Associates, Inc.

K number K863268

View details →

CJE 1986-09-26

ALKALINE PHOSPHATASE TEST

Applicant King Diagnostics, Inc.

K number K862498

View details →

CJE 1986-09-09

ALP S.C.E.

Applicant J. D. Assoc.

K number K863051

View details →

CJE 1986-08-29

ALP (OPT) REAGENT

Applicant Sigma Diagnostics, Inc.

K number K862905

View details →

CJE 1986-07-01

ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET

Applicant Sterling Diagnostics, Inc.

K number K862256

View details →

CJE 1986-05-29

ALKALINE PHOSPHATASE PROCEDURE

Applicant Data Medical Associates, Inc.

K number K861667

View details →

CJE 1986-05-29

KINETIC ALKALINE PHOSPHATASE REAGENT KIT

Applicant Bio-Analytics Laboratories, Inc.

K number K861638

View details →

CJE 1986-04-28

AP REAGENT CARTRIDGE

Applicant Hi Chem, Inc.

K number K861284

View details →

CJE 1986-04-24

ALP (ALKALINE PHOSPHATASE) REAGENT

Applicant Trace Scientific , Ltd.

K number K860715

View details →

CJE 1986-02-06

EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT

Applicant Em Diagnostic Systems, Inc.

K number K860134

View details →

CJE 1985-08-21

IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN

Applicant Clinical Data, Inc.

K number K852441

View details →

CJE 1985-07-23

AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE

Applicant American Research Products Co.

K number K852752

View details →

CJE 1985-07-22

ALKALINE PHOSPHATASE

Applicant Advanced Biomedical Methods, Inc.

K number K852784

View details →

CJE 1985-05-30

ALP(ALKALINE)(PHOSPHATASE) REAGENT

Applicant Alpkem Corp.

K number K851998

View details →

CJE 1985-01-29

VISION -FORMERLY PDA- ALKALINE PHOSPHATASE

Applicant Abbott Laboratories

K number K850110

View details →

CJE 1984-09-14

ALKALINE PHOSPHATASE REAGENT SET

Applicant Sterling Biochemical, Inc.

K number K843332

View details →

CJE 1984-09-13

SYSTEMATE ALKALINE PHOSPHATASE-67203

Applicant Em Diagnostic Systems, Inc.

K number K843270

View details →

CJE 1984-07-18

ALKALINE PHOSPHATASE ASSAY KIT

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K842243

View details →

CJE 1984-06-14

SIGMA PROCED. 245 ALKALINE PHOSPHATASE

Applicant Sigma Diagnostics, Inc.

K number K841918

View details →

CJE 1984-01-30

KINETIC ALKALINE PHOSPHATASE

Applicant American Monitor Corp.

K number K834033

View details →

CJE 1984-01-13

ALKALINE PHOSPHATASE-RATE

Applicant Seragen Diagnostics, Inc.

K number K833744

View details →

CJE 1983-09-12

RAICHEM ALKALINE PHOSPHATASE REAGENT

Applicant Reagents Applications, Inc.

K number K832463

View details →

CJE 1983-06-22

PARAMAX ALKALINE PHOSPHATASE REAGENT-

Applicant American Dade

K number K831480

View details →

CJE 1983-06-08

DATA-ZYME ALKALINE PHOSPHATASE PROCED

Applicant Data Medical Associates, Inc.

K number K831360

View details →

CJE 1983-01-14

ALKALINE PHOSPHATASE

Applicant Analytical & Research Chemicals, Inc.

K number K823786

View details →

CJE 1982-11-22

DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI

Applicant Boehringer Mannheim Corp.

K number K823213

View details →

CJE 1982-07-13

ULTRAZYME PLUS ALP

Applicant Harleco Diagnostics

K number K821870

View details →

CJE 1982-06-02

ULTRAZYME PLUS ALP #64962,65029&65030

Applicant Emd Chemicals, Inc.

K number K821471

View details →

CJE 1981-11-02

GILCHEM ALP REAGENT

Applicant Gilford Diagnostics

K number K812912

View details →

CJE 1981-09-29

ULTRA ZYME PLUS ALP #64962, 65029 & 30

Applicant Harleco

K number K812596

View details →

CJE 1981-09-09

ALKALINE PHOSPHATASE

Applicant Pointe Scientific, Inc.,

K number K812452

View details →

CJE 1981-01-26

ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT

Applicant Bio-Analytics Laboratories, Inc.

K number K810082

View details →

CJE 1980-11-12

BECKMAN LIQUID STAT LIQUID/ALKALINE PHO

Applicant Beckman Instruments, Inc.

K number K802574

View details →

CJE 1980-06-20

COBAS REAGENT FOR ALKALINE PHOSPHATASE

Applicant Roche Analytical Instruments, Inc.

K number K801242

View details →