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202 FDA 510(k) clearances · Product code

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RecordFirmDate
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II (K911167)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1 (K910930)Analytical Control Systems, Inc.1991-05-01
CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL (K905457)Consolidated Technologies, Inc.1991-04-16
CHALLENGE (TM) LIQ THERA DRUG CONTROLS (K910333)Medical Analysis Systems, Inc.1991-04-12
DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS (K904905)Medical Analysis Systems, Inc.1990-12-11
BLIND CONTROLS FOR DRUGS OF ABUSE TESTING (K903909)Rapid Diagnostic Laboratories, Inc.1990-10-26
KODATROL LIQUID CONTROL LEVELS I & II (K903189)Eastman Kodak Company1990-08-22
LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN (K901270)Bio-Rad1990-05-02
LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM (K901271)Bio-Rad1990-04-11
ALPHA URINE SAMPLE (K900626)Toxi-Lab, Inc.1990-03-06
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III (K892380)Baxter Healthcare Corp1990-02-08
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG. (K895816)Bio-Rad1989-12-07
KIT- CIBA CORNING L-TDM I, II, III (K893682)Ciba Corning Diagnostics Corp.1989-09-28
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE (K893835)Ciba Corning Diagnostics Corp.1989-07-25
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL: (K890957)Hycor Biomedical, Inc.1989-03-09
DRUG CONTROL SET (K884178)Gelman Sciences, Inc.1989-02-17
DETECTABUSE DRUG CONTROLS (K890406)Eastern Laboratories, Ltd.1989-02-10
NEW LOW LEVEL DRUG MIXTURE CONTROL (K890030)Rapid Diagnostic Laboratories, Inc.1989-01-23
EMIT (R) HVA NEGATIVE URINE (K883210)Syva Co.1988-09-19
DADE TDM CONTROL (K883190)Baxter Healthcare Corp1988-09-09
EMIT HVA CONTROL KIT (K881944)Syva Co.1988-07-08
LYPHOCHEK URINE TOXICOLOGY CONTROL (K881989)Bio-Rad1988-06-20
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL (K880145)Bio-Rad1988-06-20
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE (K881991)Bio-Rad1988-06-20
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW (K881990)Bio-Rad1988-06-20
PAR(TM) BRAND DRUG OF ABUSE CONTROLS (K880152)Medical Analysis Systems, Inc.1988-05-31
DRUG MIXTURE CONTROL IN URINE (K880512)Eastern Laboratories, Ltd.1988-04-05
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW (K880445)Bio-Rad1988-04-05
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE (K880444)Bio-Rad1988-02-25
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III (K874757)Baxter Healthcare Corp1988-02-02
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS (K873183)Abbott Laboratories1987-11-23
ACA URINE DRUGS OF ABUSE CONTROL (K873539)E.I. Dupont DE Nemours & Co., Inc.1987-10-07
CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL (K873037)Diagnostic Products Corp.1987-10-02
QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL (K873467)Quantimetrix Medical Industries1987-09-29
HYPERFORMANCE CONTROLS (HP-CONTROLS) (K871694)Rapid Diagnostic Laboratories, Inc.1987-07-07
LIQUID TDM CONTROLS (K871788)Biological Industries1987-06-17
TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG (K870586)Medical Analysis Systems, Inc.1987-04-01
QUANTIMETRIX DRUG FREE SERUM CONTROL (K863388)Quantimetrix Corp.1986-09-29
LYPHOCHEK URINE TOXICOLOGY CONTROL (K861970)Bio-Rad1986-08-19
V-TREND QC TDM CONTROL SERUM 1,2,3. (K862817)Texas Immunology, Inc.1986-08-19
THERACHEM, TDC THERAPEUTIC DRUG CONTROLS (K860919)Fisher Scientific Co., LLC1986-04-11
THERAPEUTIC DRUG (TDM) CALIBRATOR (K860097)Instrumentation Laboratory CO1986-02-11
QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL (K853933)Quantimetrix Corp.1985-10-04
LYPHOCHEK DRUG FREE SERUM(HUMAN) (K852414)Bio-Rad1985-07-24
EMIT IMIPRAMINE/DESIPRAMINE CONTROL (K844945)Syva Co.1985-01-18
EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL (K844946)Syva Co.1985-01-18
COBAS FP TDM CONTROLS (K843913)Roche Diagnostic Systems, Inc.1984-10-30
HUMAN SERUM ANTICONVULSANT DRUG CONTROL (K843818)Quantimetrix Corp.1984-10-30
HUMAN SERUM CARDIOACTIVE DRUG CONTROL (K843679)Quantimetrix Corp.1984-10-05
EMIT 700 CONTROL SET B (K843508)Syva Co.1984-09-28
EMIT 700 CONTROL SET A (K843161)Syva Co.1984-08-29
COMA TOXICOLOGY CONTROL (K841439)American Dade1984-05-16
THERACHEM TDC THERAPEUTIC DRUG CONTROL (K840921)Fisher Diagnostics1984-04-05
LIQUI-URA TOXIC URINE CONTROL (K834259)Biodiagnostic Intl1984-01-30
LYPHOCHEK THERAPEUTIC DRUG CONTROL (K833794)Bio-Rad1984-01-24
TRICYCLIC ANTIDEPRESSANTS (K831736)Utak Laboratories, Inc.1983-07-28
AMOXAPINE 8-HYDRO-XYAMOXAPINE (K831734)Utak Laboratories, Inc.1983-07-26
FLURAZEPAM TOXICOLOGY CONTROL (K831741)Utak Laboratories, Inc.1983-07-26
TRICYCLIC ANTIDEPRESSNATS VI (K831737)Utak Laboratories, Inc.1983-07-19
DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE (K831740)Utak Laboratories, Inc.1983-07-06
TRI-LEVEL TDM CONTROL & I II III (K831500)Ortho Diagnostic Systems, Inc.1983-06-30
LIQUI-SERA ANTICONVULSANTS CONTROLS (K831278)Biodiagnostic Intl1983-05-27
EMIT-ST PHOTOMETER & DILUTER VERIFICA (K830518)Syva Co.1983-04-05
CONTOX DURG CONTROL (K830492)Kaulson Laboratories, Inc.1983-03-11
CONTOX DRUG SCREEN CONTROL (K830494)Kaulson Laboratories, Inc.1983-03-11
CONTOX HEAVYMETALS CONTROL (K830234)Kaulson Laboratories, Inc.1983-02-18
ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG (K823746)Syva Co.1983-01-12
THERAPEUTIC DRUG CONTROL (K822777)Icl Scientific1982-10-08
ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX (K821975)Ortho Diagnostic Systems, Inc.1982-08-27
Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED (K821950)Travenol Laboratories, S.A.1982-07-20
Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY. (K821973)Travenol Laboratories, S.A.1982-07-20
STRATUS TDM CONTROL, LEVELS I,II,III (K820296)American Dade1982-05-14
PROFILE GENERAL SET ASSAYED SERUM CONTR (K820468)General Diagnostics1982-03-25
EMIT-ST URINE CONTROLS SET A #3A349 (K820462)Syva Co.1982-03-11
CONTROL SET (K820191)Syva Co.1982-02-12
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL (K813349)Stanbio Laboratory1981-12-22
QAC CONTROL (K812950)The Quality Assurance Service Corp.1981-12-17
THERAPEUTIC DRUG CONTROL (K811756)Icl Scientific1981-07-15
ANTI-ARRHYTHMIC CONTROL LEVELS I & II (K811809)Environmental Chemical Specialties1981-07-10
TDM ANTI-CONVULSANT CONTROL LEVELS I-II (K811811)Environmental Chemical Specialties1981-07-10
EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL (K811618)Syva Co.1981-06-25
THERACHEM ANTI CONVULSANTA THEOPHYLLINE (K810504)Fisher Scientific Co., LLC1981-03-11
EMIT-ST SERUM CONTROLS (K810468)Syva Co.1981-03-06
ACETAMINOPHEN/SALICYLATE CONTROL (K810235)Clin Tech Diagnostics Corp.1981-02-10
Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S (K810078)Hyland Therapeutic Div., Travenol Laboratories1981-02-02
OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. (K810077)Hyland Therapeutic Div., Travenol Laboratories1981-01-28
PROFILE CARDIAC SET ASSAYED SERUM CONTR. (K803036)General Diagnostics1980-12-22
DIGOXIN & PHENYTOIN CONTROL SERA (K803097)Amersham Corp.1980-12-22
PROFILE ANTI-CONVUL. SET ASSAYED S. CTL. (K803039)General Diagnostics1980-12-22
BECKMAN ICS DRUG CONTROL SERA (K802854)Beckman Instruments, Inc.1980-12-11
IN VITRO DIAGNOSTIC STANDARDS (K802278)Supelco, Inc.1980-11-24
CARDIOACTIVE DRUGS CONTROL (K802672)Fisher Scientific Co., LLC1980-11-24
TRICYCLIC ANTIDEPRESSANTS I TX CONTROL (K800888)Utak Laboratories, Inc.1980-05-02
ANTICONVULSANTS TOXICOLOGY CONTROL (K800882)Utak Laboratories, Inc.1980-04-29
CARDIACS II TOXICOLOGY CONTROL (K800884)Utak Laboratories, Inc.1980-04-29
BARBITURATES TOXICOLOGY CONTROL (K800885)Utak Laboratories, Inc.1980-04-29
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL (K800886)Utak Laboratories, Inc.1980-04-29
HYPNOTICS PLUS SALICYLATE TX CONTROL (K800887)Utak Laboratories, Inc.1980-04-29
CARDIACS I TOXICOLOGY CONTROL (K800883)Utak Laboratories, Inc.1980-04-29
TRICYCLIC ANTIDEPRESSANT II TX CONTROL (K800889)Utak Laboratories, Inc.1980-04-29
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