Drug Specific Control Materials

FDA product code LAS · 83 cleared devices

Class 1 Clinical Toxicology

Regulation: 21 CFR 862.3280
Review panel: TX
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-10-07 – 2009-11-17

LAS 2009-11-17

CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS

Applicant Chromsystems Instruments & Chemicals GmbH

K number K080459

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LAS 2008-01-30

MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL

Applicant More Diagnostics

K number K072257

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LAS 2006-10-30

QUANTIMETRIX NICOSURE COTININE URINE CONTROL

Applicant Quantimetrix Corp.

K number K062942

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LAS 2005-06-06

MAS IMMUNOSUPPRESSANT CONTROLS

Applicant Microgenics Corp.

K number K051074

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LAS 2004-05-27

DRI OXYCODONE ASSAY

Applicant Microgenics Corp.

K number K040411

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LAS 2003-10-17

MICROGENICS CYCLOSPORINE CONTROL KIT

Applicant Microgenics Corp.

K number K032842

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LAS 2003-03-31

CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5

Applicant Microgenics Corp.

K number K030616

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LAS 1999-07-14

REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE

Applicant Consolidated Technologies, Inc.

K number K992151

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LAS 1997-05-12

INNOFLUOR TOPIRAMATE CONTROL SET

Applicant Oxis Intl., Inc.

K number K970517

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LAS 1997-04-17

SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS

Applicant Beckman Instruments, Inc.

K number K971210

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LAS 1995-02-07

ROCHE-TDM ONLEIN(TM) CONTROLS

Applicant Roche Diagnostic Systems, Inc.

K number K946119

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LAS 1994-08-24

MICROGENICS THC CONTROL SETS

Applicant Microgenics Corp.

K number K943048

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LAS 1994-01-27

ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE

Applicant Roche Diagnostic Systems, Inc.

K number K930844

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LAS 1993-11-09

DUPONT ACA URINE METHADONE CONTROL

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

K number K934145

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LAS 1993-09-10

REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE

Applicant Consolidated Technologies, Inc.

K number K933557

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LAS 1993-07-26

CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL

Applicant More Diagnostics

K number K932662

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LAS 1992-07-16

SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)

Applicant Heraeus Kulzer, Inc.

K number K921939

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LAS 1992-04-17

CANNABINOID URINE CONTROLS

Applicant Diagnostic Reagents, Inc.

K number K921141

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LAS 1992-01-28

ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL

Applicant Roche Diagnostic Systems, Inc.

K number K915516

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LAS 1991-09-25

ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III

Applicant Analytical Control Systems, Inc.

K number K913677

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LAS 1991-08-26

ABUSCREEN(R) ONLINE(TM) CONTROLS

Applicant Roche Diagnostic Systems, Inc.

K number K913336

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LAS 1991-08-12

ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ

Applicant Roche Diagnostic Systems, Inc.

K number K913107

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LAS 1991-04-12

UTAK LABORATORIES TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K903061

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LAS 1991-04-03

LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2

Applicant Bio-Rad

K number K910829

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LAS 1991-03-11

ABUSCREEN(R) ONLINE CONTROLS

Applicant Roche Diagnostic Systems, Inc.

K number K910689

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LAS 1989-08-28

ABUSCREEN POSITIVE REFERENCE CONTROLS

Applicant Roche Diagnostic Systems, Inc.

K number K894464

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LAS 1989-08-21

ABUSCREEN TRI-LEVEL REFERENCE CONTROLS

Applicant Roche Diagnostic Systems, Inc.

K number K894463

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LAS 1989-08-03

ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE

Applicant Roche Diagnostic Systems, Inc.

K number K893860

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LAS 1989-08-03

ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE

Applicant Roche Diagnostic Systems, Inc.

K number K893859

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LAS 1989-08-03

ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC

Applicant Roche Diagnostic Systems, Inc.

K number K893858

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LAS 1989-08-03

ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE

Applicant Roche Diagnostic Systems, Inc.

K number K893857

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LAS 1989-08-03

ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE

Applicant Roche Diagnostic Systems, Inc.

K number K893856

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LAS 1989-08-03

ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES

Applicant Roche Diagnostic Systems, Inc.

K number K893855

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LAS 1989-04-21

LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3

Applicant Bio-Rad

K number K892004

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LAS 1988-11-29

DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER

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

K number K883891

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LAS 1987-10-29

QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2

Applicant Quantimetrix Medical Industries

K number K873011

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LAS 1987-07-07

DIGOXIN FPIA CONTROLS

Applicant Sigma Diagnostics, Inc.

K number K872347

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LAS 1987-07-01

PHENYTOIN FPIA CONTROLS

Applicant Sigma Diagnostics, Inc.

K number K871567

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LAS 1987-05-06

CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3

Applicant Cala Diagnostics

K number K864456

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LAS 1986-11-13

SERUM VANCOMYCIN TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K862419

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LAS 1986-11-13

BENZODIAZEPINES TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K862418

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LAS 1986-11-05

SERUM CLONAZEPAM TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K862421

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LAS 1986-09-25

HIGH PERFORMANCE CANNABINOID CONTROLS

Applicant Rapid Diagnostic Laboratories, Inc.

K number K863117

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LAS 1986-06-13

EMIT CAFFEINE CONTROL

Applicant Syva / A Syntex Co.

K number K861511

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LAS 1984-10-05

EMIT 700 CANNABINOID CONTROL SET

Applicant Syva Co.

K number K843419

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LAS 1984-05-11

ACA TRICYCLIC ANTIDEPRESSANTS SCREEN

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

K number K841533

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LAS 1983-07-26

CAFFINE TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K831738

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LAS 1983-07-26

MAPROTILINE

Applicant Utak Laboratories, Inc.

K number K831735

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LAS 1983-07-19

EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO

Applicant Syva Co.

K number K831979

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LAS 1983-07-06

PENTOBARBITAL TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K831739

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LAS 1983-06-16

EMIT QST TOBRAMYCIN CONTROL

Applicant Syva Co.

K number K831417

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LAS 1983-01-28

ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL

Applicant Syva Co.

K number K830049

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LAS 1982-12-15

ADVANCE EMIT(R) & TM AMIKACIN CONTROL

Applicant Syva Co.

K number K823369

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LAS 1982-10-27

SYVA ADVANCE EMIT AED VALPROIC ACID CONT

Applicant Syva Co.

K number K822934

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LAS 1982-06-24

EMIT - ST URINE METHAGUALONE CONTROLS

Applicant Syva Co.

K number K821766

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LAS 1982-06-02

EMIT TOX ACETAMINOPHEN CONTROL

Applicant Syva Co.

K number K821380

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LAS 1982-03-11

EMIT-AMD AMIKACIN CONTROL

Applicant Syva Co.

K number K820439

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LAS 1982-03-04

ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN

Applicant Ortho Diagnostic Systems, Inc.

K number K820392

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LAS 1982-02-23

EMIT AND NETILMICIN CONTROL

Applicant Syva Co.

K number K820323

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LAS 1982-02-23

SYVA ADVANCE SY. EMIT-AMD GENT. CONTROL

Applicant Syva Co.

K number K820286

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LAS 1982-01-29

ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN CNTRL

Applicant Syva Co.

K number K820129

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LAS 1981-12-03

EMIT-AAD THEOPHYLLINE CONTROL

Applicant Syva Co.

K number K813241

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LAS 1981-08-20

EMIT-ST CANNABINOID CONTROLS

Applicant Syva Co.

K number K812196

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LAS 1981-06-25

EMIT-ST SERUM PHENOBARBITAL CONTROLS

Applicant Syva Co.

K number K811619

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LAS 1981-06-09

EMIT-CAD QUINDINE CONTROL

Applicant Syva Co.

K number K811462

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LAS 1981-02-04

TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K810201

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LAS 1980-12-22

AMES TDA AMIKACIN CONTROL SERUM

Applicant Miles Laboratories, Inc.

K number K803107

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LAS 1980-06-17

EMIT VALPROIC ACID CONTROL

Applicant Syva Co.

K number K801206

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LAS 1980-06-09

EMIT DISOPYRAMIDE CONTROL

Applicant Syva Co.

K number K801205

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LAS 1980-04-16

BI-LEVEL ASSAYED CARD. DRUG CONT., I,II

Applicant Ortho Diagnostics, Inc.

K number K800357

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LAS 1979-12-18

TOBRAMYCIN LIQUID CONTROL SERUM

Applicant Hemometrix

K number K792264

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LAS 1979-12-18

TOBRAMYCIN CONTROL SERUM

Applicant Hemometrix

K number K792263

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LAS 1979-12-18

GENTAMICIN LIQUID CONTROL SERUM

Applicant Hemometrix

K number K792262

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LAS 1979-12-18

GENTAMICIN CONTROL SERUM

Applicant Hemometrix

K number K792261

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LAS 1979-12-18

AMIKACIN LIQUID CONTROL SERUM

Applicant Hemometrix

K number K792260

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LAS 1979-12-18

AMIKACIN CONTROL SERUM

Applicant Hemometrix

K number K792259

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LAS 1979-05-15

EMIT GENTAMICIN CONTROL

Applicant Syva Co.

K number K790830

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LAS 1979-03-15

EMIT-QUINIDINE CONTROL

Applicant Syva Co.

K number K790402

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LAS 1979-01-10

EMIT PROCAINAMIDE CONTROL SET

Applicant Syva Co.

K number K782084

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LAS 1979-01-03

CONTROL SET, EMIT METHOTREXATE

Applicant Syva Co.

K number K781827

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LAS 1978-12-07

THEOPHYLLINE CONTROL SERUM

Applicant Vitek Systems, Inc.

K number K780961

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LAS 1978-02-03

ANTICONVULSANT CONTROL SERUM

Applicant Mcdonnell Douglas Corp.

K number K780142

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LAS 1976-10-07

ANTICONVULSANT CONTROL SERUM

Applicant Bio-Reagents & Diagnostics, Inc.

K number K760730

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