Atlas FDA

DLJ

123 FDA 510(k) clearances · Product code

43 daysmedian time to decision
102 days90th percentile
123clearances measured

FDA profile

Official device name
Calibrators, Drug Specific
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3200
Medical specialty
Clinical Toxicology
Adverse events (MAUDE)
2011: 6 · 2012: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 (K132090)Randox Laboratories, Ltd.2013-08-08
QMS LIDOCAINE CALIBRATORS, MODEL 0374678 (K091617)Thermo Fisher Scientific2009-07-17
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 (K082030)Siemens Healthcare Diagnostics, Inc.2008-08-22
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 (K062182)Dade Behring, Inc.2006-09-14
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) (K062199)Dade Behring, Inc.2006-09-06
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) (K061503)Dade Behring, Inc.2006-06-22
DIMENSION TACR CALIBRATOR, MODEL DC107 (K060503)Dade Behring, Inc.2006-05-18
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 (K053108)Dade Behring, Inc.2006-02-16
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (K052015)Dade Behring, Inc.2005-09-12
LABONE MICRO-PLATE COTININE EIA (K033601)Labone, Inc.2004-02-10
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS (K033246)Roche Diagnostics Corp.2003-12-02
PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS (K033165)Roche Diagnostics Corp.2003-10-14
DRI PRIMIDONE CALIBRATORS (K023780)Microgenics Corp.2003-02-10
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K023316)Lin-Zhi International, Inc.2002-12-16
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K021449)Lin-Zhi International, Inc.2002-06-18
EMIT 2000 VANCOMYCIN CALIBRATORS (K020845)Dade Behring, Inc.2002-05-08
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K020769)Lin-Zhi International, Inc.2002-04-03
DRI ECSTASY URINE CALIBRATORS (K012109)Microgenics Corp.2001-08-27
CYCLOSPORINE CALIBRATOR (K011112)Dade Behring, Inc.2001-07-17
SYNCHRON SYSTEMS DRUG CALIBRATOR 2 (K993473)Beckman Coulter, Inc.1999-11-26
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS (K993022)Beckman Coulter, Inc.1999-11-09
ABUSCREEN ONLINE BENZ 300 CALIBRATORS (K983556)Roche Diagnostic Systems, Inc.1998-12-15
ABUSCREEN ONLINE BENZ 200 CALIBRATORS (K983555)Roche Diagnostic Systems, Inc.1998-12-15
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K981926)Emd Chemicals, Inc.1998-07-22
ACE PHENOBARBITAL REAGENT/AED CALIBRATORS (K973536)Schiapparelli Biosystems, Inc.1997-11-06
50NG/ML COCAINE METABOLITE CALIBRATOR (K972835)Diagnostic Reagents, Inc.1997-08-28
CEDIA DIGOXIN CALIBRATORS (K972433)Boehringer Mannheim Corp.1997-07-24
INNOFLOUR CALIBRATOR REAGENT SET (K970509)Oxis Intl., Inc.1997-05-12
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR (K962280)Roche Diagnostic Systems, Inc.1996-08-16
ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 (K961726)Roche Diagnostic Systems, Inc.1996-07-11
STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION (K940048)Solarcare Technologies Corp,Inc.1996-03-19
CEDIA DAU LSD CALBIRATORS (K955813)Microgenics Corp.1996-02-09
CEDIA DAU PPX/METH CALIBRATOR (K951153)Microgenics Corp.1995-04-21
THEOPHYLLINE CALIBRATORS (K945338)Diagnostic Reagents, Inc.1995-01-17
PHENOBARBITAL CALIBRATORS (K945316)Diagnostic Reagents, Inc.1995-01-04
PHENYTOIN CALIBRATORS (K945337)Diagnostic Reagents, Inc.1994-12-07
CEDIA DAU THC CALIBRATORS (K935795)Microgenics Corp.1994-04-06
ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS (K932548)Roche Diagnostic Systems, Inc.1993-12-29
DUPONT ACA URINE METHADONE CALIBRATOR (K934144)E.I. Dupont DE Nemours & Co., Inc.1993-11-09
ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR (K933279)Roche Diagnostic Systems, Inc.1993-08-09
URINE CALIBRATOR AND CONTROL (K931506)Diagnostic Reagents, Inc.1993-07-28
THC URINE CALIBRATORS (K923386)Diagnostic Reagents, Inc.1992-09-14
THC URINE CALIBRATORS (K920749)Diagnostic Reagents, Inc.1992-03-18
DIGITOXIN FPIA CALIBRATOR SET (K915464)Sigma Diagnostics, Inc.1992-01-15
INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET (K913186)Intl. Bioclinical, Inc.1991-08-30
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS (K912048)Roche Diagnostic Systems, Inc.1991-07-26
INNOFLUOR VALPROIC ACID CALIBRATOR SET (K911466)Intl. Bioclinical, Inc.1991-05-23
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS (K910086)Roche Diagnostic Systems, Inc.1991-01-17
EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS (K904569)Syva Co.1990-12-26
DUPONT SALICYLATE CALIBRATOR (K904307)E.I. Dupont DE Nemours & Co., Inc.1990-11-06
DUPONT DRUG CLIBRATOR-B (K904303)E.I. Dupont DE Nemours & Co., Inc.1990-10-26
DUPONT ALCOHOL CALIBRATOR (K904308)E.I. Dupont DE Nemours & Co., Inc.1990-10-12
INNOFLUOR (TM) AMIKACIN CALIBRATOR SET (K903101)Innotron of Oregon, Inc.1990-08-22
N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT (K895572)Tudor Laboratories, Inc.1989-10-30
INNOFLUOR DIGOXIN CALIBRATOR SET (K895826)Innotron of Oregon, Inc.1989-10-30
PRIMIDONE (FPIA) CALIBRATOR KIT (K895568)Tudor Laboratories, Inc.1989-09-28
VALPROIC ACID (FPIA) CALIBRATOR KIT (K895570)Tudor Laboratories, Inc.1989-09-28
FPR DIGOXIN CALIBRATOR KIT (K894522)Colony Laboratories, Inc.1989-09-25
FPR THEOPHYLLINE CALIBRATOR KIT (K894530)Colony Laboratories, Inc.1989-09-18
FPR TOBRAMYCIN CALIBRATOR KIT (K894532)Colony Laboratories, Inc.1989-09-01
FPR CARBAMAZEPINE CALIBRATOR KIT (K894520)Colony Laboratories, Inc.1989-08-28
FPR PHENOBARBITAL CALIBRATOR KIT (K894526)Colony Laboratories, Inc.1989-08-28
INNOFLUOR CARBAMAZEPINE CALIBRATOR SET (K893506)Innotron of Oregon, Inc.1989-08-15
INNOFLUOR(TM) QUINDINE CALIBATOR SET (K892212)Innotron of Oregon, Inc.1989-06-09
ACA VANCOMYCIN CALIBRATOR (K892901)E.I. Dupont DE Nemours & Co., Inc.1989-05-16
EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR (K890451)Syva Co.1989-02-10
EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR (K890452)Syva Co.1989-02-10
DU PONT ACA METHOTREXATE CALIBRATOR (K884745)E.I. Dupont DE Nemours & Co., Inc.1989-01-30
ANALYST THEOPHYLLINE CALIBRATOR (K884170)The DU Pont Co.1988-11-16
EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A (K883920)Syva Co.1988-10-11
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95 (K881337)Em Diagnostic Systems, Inc.1988-05-27
EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL (K875135)Syva Co.1988-04-05
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95 (K874101)Em Diagnostic Systems, Inc.1987-11-09
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95 (K874102)Em Diagnostic Systems, Inc.1987-11-05
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95 (K873436)Em Diagnostic Systems, Inc.1987-10-29
CARBAMAZEPINE (FPIA) CALIBRATOR KIT (K873281)Windsor Laboratories, Inc.1987-10-28
INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET (K872349)Innotron of Oregon, Inc.1987-07-21
INNOFLUOR PHENYTOIN CALIBRATOR SET (K872142)Innotron of Oregon, Inc.1987-07-21
INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET (K872461)Innotron of Oregon, Inc.1987-07-21
INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET (K872462)Innotron of Oregon, Inc.1987-07-21
INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET (K872463)Innotron of Oregon, Inc.1987-07-21
ETHANOL CALIBRATOR (K872181)American Monitor Corp.1987-07-21
INNOFLUOR VANCOMYCIN CALIBRATOR SET (K872644)Innotron of Oregon, Inc.1987-07-21
DIGOXIN FPIA CALIBRATORS (K872328)Sigma Chemical Co.1987-07-07
PHENYTOIN FPIA CALIBRATORS (K871423)Sigma Diagnostics, Inc.1987-06-11
THEOPHYLLINE FPIA CALIBRATORS (K871394)Sigma Diagnostics, Inc.1987-06-01
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95 (K871330)Em Diagnostic Systems, Inc.1987-04-22
DIGOXIN (FPIA) CALIBRATOR KIT (K870389)Windsor Laboratories, Inc.1987-04-01
PHENOBARBITAL (FPIA) CALIBRATOR KIT (K870390)Windsor Laboratories, Inc.1987-04-01
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93 (K870247)Em Diagnostic Systems, Inc.1987-02-11
AMIKACIN (FPIA) CALIBRATOR KIT (K863244)Windsor Laboratories, Inc.1986-08-29
ANTIASTHMATIC CALIBRATORS (K862964)American Monitor Corp.1986-08-19
EMIT COLUMN DIGOXIN CALIBRATORS (K861395)Syva Co.1986-05-07
DU PONT DIGOXIN ASSAY CALIBRATOR (K850457)E.I. Dupont DE Nemours & Co., Inc.1985-03-05
DU PONT TOBRAMYCIN ASSAY CALIBRATOR (K850057)E.I. Dupont DE Nemours & Co., Inc.1985-01-18
DU PONT GENTAMICIN ASSAY CALIBRATOR (K850059)E.I. Dupont DE Nemours & Co., Inc.1985-01-18
EMIT 700 CANNABINOID CALIBRATOR (K843420)Syva Co.1984-09-26
AMIKACIN CALIBRATOR ACA (K843210)E.I. Dupont DE Nemours & Co., Inc.1984-09-14
EMIT D.A.U. URINE CANNABINOID CALIBRA (K834457)Syva Co.1984-06-22
DUPONT THEOPHYLLINE DIT CALIBRATOR (K841655)E.I. Dupont DE Nemours & Co., Inc.1984-05-16
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