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JJX

493 FDA 510(k) clearances · Product code

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RecordFirmDate
RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II (K922904)Reagents Applications, Inc.1992-07-30
TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL (K921252)Hybritech, Inc.1992-07-17
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET (K920556)Hybritech, Inc.1992-07-17
LYPHOCHEK(R) FRUCTOSAMINE CONTROL (K921089)Bio-Rad1992-04-29
HCG CONTROL (K921206)Polymedco, Inc.1992-04-29
TSH CONTROL (K915325)Polymedco, Inc.1992-03-02
MILENIA DATA REDUCTION (K915806)Diagnostic Products Corp.1992-01-30
MP MINI PHOTOMETER (K914809)Artel, Inc.1992-01-27
LIPASE LINEARITY CONTROL (K913585)Creative Laboratory Products, Inc.1991-10-21
QUANTIMETRIX AMMONIA CONTROLS (K913346)Quantimetrix Corp.1991-09-25
HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL (K913792)Hichem Diagnostics1991-09-25
CHOLINESTERASE LINEARITY CONTROL (K913496)Creative Laboratory Products, Inc.1991-09-11
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET (K912439)Hybritech, Inc.1991-08-28
DIRECTIGEN 1-2-3 PREGNANCY CONTROLS (K911664)Quidel Corp.1991-05-31
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III (K911178)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II (K911177)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I (K911176)Analytical Control Systems, Inc.1991-05-01
BIOTROL BILIRUBIN C & T CONTROL (K905280)Biotrol, USA, Inc.1991-02-04
SERACON CR REFERENCE (K904503)Bhp Diagnostix, Inc.1990-11-02
DUPONT DRUG CALIBRATOR-A (K904306)E.I. Dupont DE Nemours & Co., Inc.1990-10-15
PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF (K902569)Boehringer Mannheim Corp.1990-08-09
CHEM-CHEX-ALT (K903147)Streck Laboratories, Inc.1990-08-09
AMERSHAM TSH CONTROL SERA (K902760)Amersham Corp.1990-07-27
CHEM-CHEX BILIRUBIN (K902867)Streck Laboratories, Inc.1990-07-16
ROTAG CONTROLS (K900719)Roche Diagnostic Systems, Inc.1990-05-30
POSITIVE AND NEGATIVE HCG SERUM CONTROLS (K896875)Armkel, LLC1990-02-26
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 (K895528)Helena Laboratories1989-10-25
MICRO-PLATE READER, MDX-1 (K894400)Medix Biotech, Inc.1989-10-23
SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) (K894804)Lifescan, Inc.1989-09-28
RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL (K894329)Amersham Corp.1989-09-05
POSITIVE AND NEGATIVE HCG URINE CONTROLS (K894181)Armkel, LLC1989-08-31
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3 (K891475)Bio-Rad1989-08-01
DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET (K893140)Casco Standards1989-06-23
ASSAYED CHOLINESTERASE CONTROL (K885282)Actio, Inc.1989-06-09
DRI-DYE CHECK STRIPS (TM)-405 (K892656)Awareness Technology, Inc.1989-05-22
QTEST PREGNANCY TEST CONTROL (K883741)Quidel Corp.1988-10-03
QUIDEL PREGNANCY TEST CONTROL (K883316)Quidel Corp.1988-09-22
LIQUI-SERA SERUM ALCOHOL CONTROLS (K881430)Biodiagnostic Intl1988-07-08
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665 (K880039)Sigma Diagnostics, Inc.1988-02-24
BILE ACIDS CONTROLS (K873342)Sigma Diagnostics, Inc.1987-10-20
TRI-LEVEL LIGAND CONTROL (K873450)Ciba Corning Diagnostics Corp.1987-09-21
REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL (K873105)Streck Laboratories, Inc.1987-09-16
TOTAL/IGE THEOPHYLLINE CONTROL SERA (K870151)3M Company1987-03-12
HCG CONTROL KIT (K863744)Monoclonal Antibodies, Inc.1986-11-05
TESTPACK ACUTE HCG SERUM CONTROLS (K863126)Abbott Laboratories1986-09-15
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST (K861221)Em Diagnostic Systems, Inc.1986-04-24
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 (K860453)Sigma Diagnostics, Inc.1986-02-19
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL (K855225)Boehringer Mannheim Corp.1986-01-17
DIASCAN CONTROL (K853553)Home Diagnostics, Inc.1985-09-16
SUGAR-CHEX II (K851043)Streck Laboratories, Inc.1985-04-29
SUGAR-CHEX (K851042)Streck Laboratories, Inc.1985-04-29
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3 (K851079)Beckman Instruments, Inc.1985-04-10
PRECISET AMMONIA (K843569)Boehringer Mannheim Corp.1984-09-28
TRI-LEVEL BILIRUBIN CONTROLS (K833898)Sandare Chemical Co., Inc.1984-01-13
CHEM TRAK LIQUID BILIRUBIN CONTROL (K833097)Medical Analysis Systems, Inc.1984-01-11
BETA SCAN NORMAL CONTROL SOLUTION (K831523)Orange Medical Instruments, Inc.1983-07-19
SPINAL FLUID TOTAL PROTEIN CONTROL (K831527)Quantimetrix Corp.1983-07-18
PROTOPORPHYRIN ZN CONTROL (K830493)Kaulson Laboratories, Inc.1983-04-18
PHADEBAS HUMYLASE CONTROL(H) (K823421)Pharmacia, Inc.1983-04-05
DAC-CEL DIAGNATAL HCG STANDARDS RD49 (K830204)Wellcome Diagnostics1983-02-18
BIO INTERFERENCE BLANKING MATERIAL (K823687)American Monitor Corp.1983-01-07
ESTROCEPT STABILIZED ESTROGEN RECEPTOR (K823186)Brl1983-01-07
HUMAN PLASMA CONTROL FOR CEA-ROCHE (K822219)Hoffmann-La Roche, Inc.1982-12-28
CARCINO-CEK (K823353)Biologics Intl., Inc.1982-12-14
PHADEBASE HUMYLASE CONTROL (K822938)Pharmacia, Inc.1982-11-05
GLUCOSCAN CONTROLS (K822698)Lifescan, Inc.1982-09-30
POSITIVE & NEGATIVE HCG URINE CONTROLS (K821742)Armkel, LLC1982-07-02
LEVEL II CONTROL SERUM (K821558)Irvine Scientific1982-07-02
FETAL-TEK CONTROL (IMMATURE/BORDERLINE) (K820772)Helena Laboratories1982-05-12
C-PEPTIDE CONTROL PACK (K812690)Mallinckrodt Critical Care1981-10-06
HELENA VMA-SMC CONTROL (K811912)Helena Laboratories1981-07-23
PRECINORM U & PRECIPATH U HUMAN SERUM (K811832)Boehringer Mannheim Corp.1981-07-15
URINE PREGNANCY TEST STANDARD/CONTR. PK (K811150)Mallinckrodt Critical Care1981-05-15
HDL-CHOLESTEROL CONTROL SERUM (K802997)Isolab, Inc.1980-12-22
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO (K802068)Beckman Instruments, Inc.1980-10-10
SPINAL FLUID CONTROL(HUMAN) (K801854)Environmental Chemical Specialties1980-09-16
CODE QAS.105 PROLACTIN CONTROL SERA (K800708)Amersham Corp.1980-04-16
PENTEX LIPOPROTEIN CHOLESTEROL SOLU. (K800035)Miles Laboratories, Inc.1980-01-21
CK-MB (CREATINE KINASE-MB) RIA CONTROL (K792524)Mallinckrodt Critical Care1980-01-16
SERACON -LO DO26 (K791957)Bhp Diagnostix, Inc.1979-10-11
BILIRUBIN CALIBRATOR CONTROL (K791141)Beckman Instruments, Inc.1979-08-10
ABNORMAL PROTEIN ELECTROPHORESIS CONTROL (K791031)Beckman Instruments, Inc.1979-07-17
NORMAL PROTEIN ELECTROPHORESIS CONTROL (K791029)Beckman Instruments, Inc.1979-07-17
DUPONT ACA CKMB VERIFIERS (K790376)E.I. Dupont DE Nemours & Co., Inc.1979-04-04
SERUM PAK, HCG CONTROL (K790129)Mallinckrodt Critical Care1979-03-21
SERACON-LP (K782170)Bhp Diagnostix, Inc.1979-02-15
SERACON-HDL (K782171)Bhp Diagnostix, Inc.1979-02-08
ACA LIPASE VERIFIERS (K772285)E.I. Dupont DE Nemours & Co., Inc.1978-01-06
ACA BILIRUBIN CALIBRATOR (K771798)E.I. Dupont DE Nemours & Co., Inc.1977-10-28
EMIT THYROXINE CONTROL (K771657)Syva Co.1977-10-13
SHAVE PREP SET (K770795)Lukens Corp.1977-07-11
KETOTROL-E (K760885)Sigma Chemical Co.1976-11-05
LIPID CONTROL (K760449)Sigma Chemical Co.1976-10-29
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