Atlas FDA

LAS

83 FDA 510(k) clearances · Product code

39 daysmedian time to decision
133 days90th percentile
83clearances measured

FDA profile

Official device name
Drug Specific Control Materials
Device class
Class I (low risk)
Regulation
21 CFR 862.3280
Medical specialty
Clinical Toxicology
Adverse events (MAUDE)
2001: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS (K080459)Chromsystems Instruments & Chemicals GmbH2009-11-17
MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (K072257)More Diagnostics2008-01-30
QUANTIMETRIX NICOSURE COTININE URINE CONTROL (K062942)Quantimetrix Corp.2006-10-30
MAS IMMUNOSUPPRESSANT CONTROLS (K051074)Microgenics Corp.2005-06-06
DRI OXYCODONE ASSAY (K040411)Microgenics Corp.2004-05-27
MICROGENICS CYCLOSPORINE CONTROL KIT (K032842)Microgenics Corp.2003-10-17
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (K030616)Microgenics Corp.2003-03-31
REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (K992151)Consolidated Technologies, Inc.1999-07-14
INNOFLUOR TOPIRAMATE CONTROL SET (K970517)Oxis Intl., Inc.1997-05-12
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (K971210)Beckman Instruments, Inc.1997-04-17
ROCHE-TDM ONLEIN(TM) CONTROLS (K946119)Roche Diagnostic Systems, Inc.1995-02-07
MICROGENICS THC CONTROL SETS (K943048)Microgenics Corp.1994-08-24
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE (K930844)Roche Diagnostic Systems, Inc.1994-01-27
DUPONT ACA URINE METHADONE CONTROL (K934145)E.I. Dupont DE Nemours & Co., Inc.1993-11-09
REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE (K933557)Consolidated Technologies, Inc.1993-09-10
CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL (K932662)More Diagnostics1993-07-26
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) (K921939)Heraeus Kulzer, Inc.1992-07-16
CANNABINOID URINE CONTROLS (K921141)Diagnostic Reagents, Inc.1992-04-17
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL (K915516)Roche Diagnostic Systems, Inc.1992-01-28
ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III (K913677)Analytical Control Systems, Inc.1991-09-25
ABUSCREEN(R) ONLINE(TM) CONTROLS (K913336)Roche Diagnostic Systems, Inc.1991-08-26
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ (K913107)Roche Diagnostic Systems, Inc.1991-08-12
UTAK LABORATORIES TOXICOLOGY CONTROL (K903061)Utak Laboratories, Inc.1991-04-12
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2 (K910829)Bio-Rad1991-04-03
ABUSCREEN(R) ONLINE CONTROLS (K910689)Roche Diagnostic Systems, Inc.1991-03-11
ABUSCREEN POSITIVE REFERENCE CONTROLS (K894464)Roche Diagnostic Systems, Inc.1989-08-28
ABUSCREEN TRI-LEVEL REFERENCE CONTROLS (K894463)Roche Diagnostic Systems, Inc.1989-08-21
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE (K893856)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC (K893858)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES (K893855)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE (K893859)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE (K893860)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE (K893857)Roche Diagnostic Systems, Inc.1989-08-03
LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3 (K892004)Bio-Rad1989-04-21
DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER (K883891)E.I. Dupont DE Nemours & Co., Inc.1988-11-29
QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2 (K873011)Quantimetrix Medical Industries1987-10-29
DIGOXIN FPIA CONTROLS (K872347)Sigma Diagnostics, Inc.1987-07-07
PHENYTOIN FPIA CONTROLS (K871567)Sigma Diagnostics, Inc.1987-07-01
CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 (K864456)Cala Diagnostics1987-05-06
SERUM VANCOMYCIN TOXICOLOGY CONTROL (K862419)Utak Laboratories, Inc.1986-11-13
BENZODIAZEPINES TOXICOLOGY CONTROL (K862418)Utak Laboratories, Inc.1986-11-13
SERUM CLONAZEPAM TOXICOLOGY CONTROL (K862421)Utak Laboratories, Inc.1986-11-05
HIGH PERFORMANCE CANNABINOID CONTROLS (K863117)Rapid Diagnostic Laboratories, Inc.1986-09-25
EMIT CAFFEINE CONTROL (K861511)Syva / A Syntex Co.1986-06-13
EMIT 700 CANNABINOID CONTROL SET (K843419)Syva Co.1984-10-05
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN (K841533)E.I. Dupont DE Nemours & Co., Inc.1984-05-11
MAPROTILINE (K831735)Utak Laboratories, Inc.1983-07-26
CAFFINE TOXICOLOGY CONTROL (K831738)Utak Laboratories, Inc.1983-07-26
EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO (K831979)Syva Co.1983-07-19
PENTOBARBITAL TOXICOLOGY CONTROL (K831739)Utak Laboratories, Inc.1983-07-06
EMIT QST TOBRAMYCIN CONTROL (K831417)Syva Co.1983-06-16
ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL (K830049)Syva Co.1983-01-28
ADVANCE EMIT(R) & TM AMIKACIN CONTROL (K823369)Syva Co.1982-12-15
SYVA ADVANCE EMIT AED VALPROIC ACID CONT (K822934)Syva Co.1982-10-27
EMIT - ST URINE METHAGUALONE CONTROLS (K821766)Syva Co.1982-06-24
EMIT TOX ACETAMINOPHEN CONTROL (K821380)Syva Co.1982-06-02
EMIT-AMD AMIKACIN CONTROL (K820439)Syva Co.1982-03-11
ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN (K820392)Ortho Diagnostic Systems, Inc.1982-03-04
EMIT AND NETILMICIN CONTROL (K820323)Syva Co.1982-02-23
SYVA ADVANCE SY. EMIT-AMD GENT. CONTROL (K820286)Syva Co.1982-02-23
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN CNTRL (K820129)Syva Co.1982-01-29
EMIT-AAD THEOPHYLLINE CONTROL (K813241)Syva Co.1981-12-03
EMIT-ST CANNABINOID CONTROLS (K812196)Syva Co.1981-08-20
EMIT-ST SERUM PHENOBARBITAL CONTROLS (K811619)Syva Co.1981-06-25
EMIT-CAD QUINDINE CONTROL (K811462)Syva Co.1981-06-09
TOXICOLOGY CONTROL (K810201)Utak Laboratories, Inc.1981-02-04
AMES TDA AMIKACIN CONTROL SERUM (K803107)Miles Laboratories, Inc.1980-12-22
EMIT VALPROIC ACID CONTROL (K801206)Syva Co.1980-06-17
EMIT DISOPYRAMIDE CONTROL (K801205)Syva Co.1980-06-09
BI-LEVEL ASSAYED CARD. DRUG CONT., I,II (K800357)Ortho Diagnostics, Inc.1980-04-16
GENTAMICIN LIQUID CONTROL SERUM (K792262)Hemometrix1979-12-18
GENTAMICIN CONTROL SERUM (K792261)Hemometrix1979-12-18
TOBRAMYCIN CONTROL SERUM (K792263)Hemometrix1979-12-18
TOBRAMYCIN LIQUID CONTROL SERUM (K792264)Hemometrix1979-12-18
AMIKACIN CONTROL SERUM (K792259)Hemometrix1979-12-18
AMIKACIN LIQUID CONTROL SERUM (K792260)Hemometrix1979-12-18
EMIT GENTAMICIN CONTROL (K790830)Syva Co.1979-05-15
EMIT-QUINIDINE CONTROL (K790402)Syva Co.1979-03-15
EMIT PROCAINAMIDE CONTROL SET (K782084)Syva Co.1979-01-10
CONTROL SET, EMIT METHOTREXATE (K781827)Syva Co.1979-01-03
THEOPHYLLINE CONTROL SERUM (K780961)Vitek Systems, Inc.1978-12-07
ANTICONVULSANT CONTROL SERUM (K780142)Mcdonnell Douglas Corp.1978-02-03
ANTICONVULSANT CONTROL SERUM (K760730)Bio-Reagents & Diagnostics, Inc.1976-10-07

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