Atlas FDA

DKB

94 FDA 510(k) clearances · Product code

51 daysmedian time to decision
136 days90th percentile
94clearances measured

FDA profile

Official device name
Calibrators, Drug Mixture
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3200
Medical specialty
Clinical Toxicology
Adverse events (MAUDE)
2002: 1 · 2012: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR (K141928)Roche Diagnostics Operations (Rdo)2014-11-25
LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS (K133710)Lin-Zhi International, Inc.2014-02-21
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS (K120936)Microgenics Corporation2012-12-13
RANDOX METHAMPHETAMINE ASSAY (K092266)Randox Laboratories, Ltd.2011-05-09
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (K101752)Microgenics Corp.2011-04-08
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 (K090939)Roche Diagnostics2009-06-18
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 (K090900)Siemens Healthcare Diagnostics2009-06-01
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) (K062162)Dade Behring, Inc.2006-09-14
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) (K062121)Dade Behring, Inc.2006-08-25
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS (K060645)Roche Diagnostics Corp.2006-05-30
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K051088)Lin-Zhi International, Inc.2005-06-24
VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 (K033879)Maine Standards Co.2004-02-27
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS (K033306)Roche Diagnostics Corp.2003-12-15
DIMENSION DRUG CALIBRATOR II, MODEL DC49C (K032574)Dade Behring, Inc.2003-10-06
PRECISET TDM I AND PRECISET TDM II CALIBRATORS (K031856)Roche Diagnostics Corp.2003-08-06
PRECISET DAT PLUS I CALIBRATORS (K031775)Roche Diagnostics Corp.2003-08-05
PRECISET DAT PLUS (K021393)Quantimetrix Corp.2002-06-13
BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS (K013959)Bayer Diagnostics Corp.2002-01-29
RANDOX THERAPEUTIC DRUG CALIBRATOR (K012318)Randox Laboratories, Ltd.2001-09-12
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS (K993954)Beckman Coulter, Inc.2000-01-11
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 (K993755)Syva Co.1999-12-21
DIMENSION DRUG CALIBRATOR II, MODEL DC49B (K990255)Dade Behring, Inc.1999-02-16
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II (K983747)Beckman Coulter, Inc.1998-12-30
DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS (K983159)Diagnostic Reagents, Inc.1998-11-05
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I (K983209)Beckman Coulter, Inc.1998-11-04
DRUG CALIBRATOR II (K982871)Dade Behring, Inc.1998-10-13
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT (K981403)Beckman Instruments, Inc.1998-05-08
CEDIA DAU MULTI-DRUG CALIBRATORS (K980853)Boehringer Mannheim Corp.1998-04-21
REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE (K974699)Consolidated Technologies, Inc.1998-01-22
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (K971600)Behring Diagnostics, Inc.1997-06-25
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS (K971287)Beckman Instruments, Inc.1997-05-08
DRUG CALIBRATOR II (K962817)Dade Intl., Inc.1996-09-16
CEDIA ANTIBIOTIC TDM MULTI-CALS (K963191)Boehringer Mannheim Corp.1996-09-10
AED CALIBRATORS (K961273)Diagnostic Reagents, Inc.1996-05-15
SERUM TOX CALIBRATOR (K961372)Diagnostic Reagents, Inc.1996-05-01
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH (K954608)Boehringer Mannheim Corp.1995-12-26
EMIT IIC CALIBRATORS (K935192)Syva Co.1995-03-24
DRUGS OF ABUSE CALIBRATOR (K950139)E.I. Dupont DE Nemours & Co., Inc.1995-02-22
DOA - IMMUNOASSAY CUT-OFF CALIBRATOR (K945289)Medi-Tech, Inc.1994-12-13
ROCHE AMMONIA (VARIOUS) (K942048)Roche Diagnostic Systems, Inc.1994-10-04
URINE CALIBRATOR (K940935)Diagnostic Reagents, Inc.1994-07-06
CEDIA DAU NEGATIVE CALIBRATOR (K935793)Microgenics Corp.1994-03-14
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB (K936028)Microgenics Corp.1994-03-14
URINE CALIBRATORS AND CONTROLS MODIFICATION (K935101)Diagnostic Reagents, Inc.1994-01-27
CEDIA DAU 4-DRUG CUTOFF CALIBRATOR (K935794)Microgenics Corp.1994-01-25
CEDIA DAU 5-DRUG CALIBRATORS (K935792)Microgenics Corp.1994-01-25
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK (K935550)Roche Diagnostic Systems, Inc.1994-01-03
ABUSCREEN ONLINE(R) CALIBRATORS (K931124)Roche Diagnostic Systems, Inc.1993-08-03
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS (K932753)Roche Diagnostic Systems, Inc.1993-07-22
ABUSCREEN CALIBRATION STANDARD (K932754)Roche Diagnostic Systems, Inc.1993-07-22
ROCHE ABUSCREEN ONLINNE CALIBRATORS (K923340)Roche Diagnostic Systems, Inc.1992-08-04
URINE A CALIBRATOR (K920208)Diagnostic Reagents, Inc.1992-03-04
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) (K915003)Syva Co.1991-11-29
IL TEST(TM) DAT CAL/CONTROL SET B (K913740)Instrumentation Laboratory CO1991-10-21
IL TEST(TM) DAT CAL/CONTROL SET C (K913741)Instrumentation Laboratory CO1991-10-21
CONTROL AND LINEARITY (K910881)Gds Diagnostics1991-09-13
IL TEST(TM) DAT CALIBRATOR A( -) (K913739)Instrumentation Laboratory CO1991-09-10
ABUSCREEN(R) ONLINE(TM) CALIBRATORS (K913335)Roche Diagnostic Systems, Inc.1991-08-26
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH) (K912729)Syva Co.1991-07-22
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS (K910085)Roche Diagnostic Systems, Inc.1991-03-11
ABUSCREEN(R) ONLINE CALIBRATORS (K905828)Roche Diagnostic Systems, Inc.1991-02-04
ABUSCREEN ONLINE OPIATES CALIBRATORS (K910087)Roche Diagnostic Systems, Inc.1991-02-04
EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH) (K904764)Syva Co.1990-11-20
EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS (K903152)Syva Co.1990-08-17
EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE) (K902581)Syva Co.1990-07-27
EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2 (K902578)Syva Co.1990-07-10
EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B (K901573)Syva Co.1990-06-06
HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS (K894934)Hycor Biomedical, Inc.1989-10-17
HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS (K893815)Hycor Biomedical, Inc.1989-07-25
DRUGS OF ABUSE URINE CALIBRATORS (K892332)Hycor Biomedical, Inc.1989-05-11
DRUG STANDARD SET (K884177)Gelman Sciences, Inc.1989-02-17
URINE TOXICOLOGY STANDARD (K881320)Verichem Laboratories, Inc.1988-09-09
EMIT HVA CALIBRATOR KIT (K881943)Syva Co.1988-07-08
HIGH PERFORMANCE CALIBRATORS (K875216)Rapid Diagnostic Laboratories, Inc.1988-06-22
THERAPEUTIC DRUG STANDARD (K880705)Verichem Laboratories, Inc.1988-05-31
ACA URINE DRUGS OF ABUSE CALIBRATOR (K872392)E.I. Dupont DE Nemours & Co., Inc.1987-09-14
4-9295 BARBITURATES TEST MIX (K871174)Supelco, Inc.1987-06-11
EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 (K862403)Diagnostic Systems1986-07-11
EMIT 700 CALIBRATOR B (K843507)Syva Co.1984-09-26
EMIT 700 CALIBRATOR A (K843163)Syva Co.1984-09-12
EMIT D.A.U. LOW & MED. CALIBRATORS B (K842816)Syva Co.1984-09-05
ACA BARBITURATES SCREEN/BENZODIAZEPIN (K842386)E.I. Dupont DE Nemours & Co., Inc.1984-08-15
LIQUI-SERA TDM CALIBRATORS (K834398)Biodiagnostic Intl1984-02-03
THERAPEUTIC DRUG CONTROL (K833761)Icl Scientific1984-01-13
DRUG STANDARDS (K833276)Supelco, Inc.1984-01-01
ADVANCE SYSTEM EMITAED ANTIEPILEPTIC (K823740)Syva Co.1983-01-05
EMIT ST URINE METHAGUALONE CALIBRATOR (K821767)Syva Co.1982-06-25
EMIT-ST URINE CALIBRATOR A (#3A319 (K820461)Syva Co.1982-03-11
CALIBRATOR SET (K820190)Syva Co.1982-02-12
DRUG STANDARDS (K811674)Supelco, Inc.1981-07-15
EMIT-TOX SERUM CALIBRATORS (K811620)Syva Co.1981-06-25
EMIT-ST SERUM CALBRATOR (K810464)Syva Co.1981-03-06
EMIT-STM URINE CALIBRATORS (K802624)Syva Co.1980-11-12
EMIT-TOX SERUM CALIBRATORS (K790735)Syva Co.1979-05-03

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Every clearance here is in the API, with alerts when new ones post.