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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
REFLOTRON HDL CHOLESTEROL TEST TABS (K902568)Boehringer Mannheim Corp.1990-08-09
ROCHE ISOMUNE- CK (K903025)Roche Diagnostic Systems, Inc.1990-08-09
CHOLESTEROL (RATE) REAGENT (K902098)Sigma Chemical Co.1990-08-09
SEROZYME FREE T3 IMMUNOASSAY (K902748)Advanced Magnetics, Inc.1990-08-09
CHEM-CHEX-ALT (K903147)Streck Laboratories, Inc.1990-08-09
EZ-SCREEN:HCG (K902681)Environmental Diagnostics, Inc.1990-08-09
ABBOTT MODIFIED FACT PLUS PREGNANCY TEST (K901981)Abbott Laboratories1990-08-02
LUMATAG(TM) LH DIAGNOSTIC KIT (K902443)London Diagnostics, Inc.1990-08-02
IONOMETER EF-HK AND ACCESSORIES (K901042)Fresenius USA, Inc.1990-07-31
SYNERMED MAGNESIUM REAGENT KIT (K902919)Synermed, Inc.1990-07-31
DMA TRIGLYCERIDE (GPO) PROCEDURE (K902202)Data Medical Associates, Inc.1990-07-31
SYNERMED SERUM IRON REAGENT KIT (K902918)Synermed, Inc.1990-07-31
COULTER HDL - CHOLESTEROL REAGENT (K902174)Coulter Corp.1990-07-31
AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS (K902326)Catachem, Inc.1990-07-31
MULTI ANALYTE MIXTURE, CALIBRATORS (K902675)Phoenix Diagnostics, Inc.1990-07-31
SPECTROPHOTOMETER (MICROASSAY PLATE READERS) (K902776)Slt Labinstruments, Inc.1990-07-31
OPUS TM T-UPTAKE TEST SYSTEM (K902797)Pb Diagnostic Systems, Inc.1990-07-30
SECUTAINER (K902709)Preserve1990-07-27
TOTAL IRON FOR MANUAL/AUTOMATED (K902877)Catachem, Inc.1990-07-27
SYNERMED TRIGLYCERIDES REAGENT KIT (K903016)Synermed, Inc.1990-07-27
MICROZYME T4 ENZYME IMMUNOASSAY KIT (K902922)Immunotech Corp.1990-07-27
AMERSHAM TSH CONTROL SERA (K902760)Amersham Corp.1990-07-27
BEHRING CHROMOTIMER (K901829)Behring Diagnostics, Inc.1990-07-24
L.D.X LIPID MONITORING SYSTEM (K901900)Cholestech Corp.1990-07-24
EPC ELECTRONIC PIPETTING SYSTEM (K902592)Ulster Scientific, Inc.1990-07-19
BILIRUBIN CONTROL (K902616)Phoenix Diagnostics, Inc.1990-07-19
GENESYS 6000 GAMMA COUNTER (K900087)Laboratory Technologies, Inc.1990-07-19
IONOMETER EH-F AND ACCESSORIES (K901040)Fresenius USA, Inc.1990-07-19
BLOOD GAS/ISE CONTROLS (K902094)Phoenix Diagnostics, Inc.1990-07-19
BIURET (COLORMETRIC), TOTAL PROTEIN (K901527)American Research Products Co.1990-07-19
AFFINITY PROLACTIN TEST SYSTEM (K902698)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-07-19
BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT (K902801)Beckman Instruments, Inc.1990-07-17
LVM QUALITY CONTROL SERUM (K902235)Ciba Corning Diagnostics Corp.1990-07-17
TECHNICON RA-2000(TM) SYSTEM (K901410)Technicon Instruments Corp.1990-07-17
MODIFIED OVUGEN (K902208)Biogenex Laboratories1990-07-17
CALCIUM:ARSENAZO III (K902476)Amresco, Inc.1990-07-17
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT (K902560)Roche Diagnostic Systems, Inc.1990-07-17
CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 (K902479)Amresco, Inc.1990-07-17
HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND (K902673)Hi Chem, Inc.1990-07-17
ACID PHOSPHATASE REAGENT SET (K902495)Tech Intl. Co.1990-07-16
PTH-MM II 125I RADIOIMMUNOASSAY (RIA) (K901711)Incstar Corp.1990-07-16
CHEM-CHEX BILIRUBIN (K902867)Streck Laboratories, Inc.1990-07-16
SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY) (K902699)Actio, Inc.1990-07-16
ATAC 6000 CHEMISTRY ANALYZER (K902689)Bio-Chem Laboratories1990-07-10
PROTEIN TEST FOR URINE AND CSF (K900733)Elite Technology, Inc.1990-07-10
CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA. (K901500)Olympus Corp.1990-07-10
SODIUM REAGENT SET (K902572)Tech Intl. Co.1990-07-10
IMX ULTRASENTITIVE HTSH (K902753)Abbott Mfg., Inc.1990-07-10
MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM (K901613)Medisense, Inc.1990-07-10
PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM (K902536)Boehringer Mannheim Corp.1990-07-10
POTASSIUM REAGENT SET (K902574)Tech-Co, Inc.1990-07-10
PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM (K902573)Boehringer Mannheim Corp.1990-07-10
CREATINE KINASE-MB TEST (MB-DS) ITEM #67655 (K902483)Em Diagnostic Systems, Inc.1990-07-10
MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER (K900788)Datachem, Inc.1990-07-05
OPUS TSH TEST SYSTEM (K902333)Pb Diagnostic Systems, Inc.1990-07-05
ACCUSCAN MICROBEAD STANDARDS (K902294)Sigma Chemical Co.1990-07-03
SYNERMED TOTAL BILIRUBIN REAGENT KIT (K902328)Synermed, Inc.1990-06-28
IONOMETER EH (K901039)Fresenius USA, Inc.1990-06-28
COULTER CREATININE REAGENT (K902172)Coulter Corp.1990-06-28
CIBA CORNING MAGIC LITE LH IMMUNOASSAY (K902398)Ciba Corning Diagnostics Corp.1990-06-28
KODAK SURECELL(TM) HCG-URINE TEST KIT (K902136)Eastman Kodak Company1990-06-28
COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 (K901933)Diagnostic Products Corp.1990-06-28
HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) (K902321)Hichem Diagnostics1990-06-28
OPUS (TM) HCG (K901935)Pb Diagnostic Systems, Inc.1990-06-26
COBAS READY CALIBRATOR KIT (K897097)Roche Diagnostic Systems, Inc.1990-06-26
COBAS READY PROFILE 2 REAGENT STRIP (K896225)Roche Diagnostic Systems, Inc.1990-06-26
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 (K901475)Baxter Healthcare Corp1990-06-20
MODIFIED DELFIA ESTRADIOL KIT (K902358)Pharmacia, Inc.1990-06-18
WAKO(TM) MICRO-ALBUMIN (K902216)Wako Chemicals USA, Inc.1990-06-18
CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE (K902336)Ciba Corning Diagnostics Corp.1990-06-18
IONOMETER EH-HK AND ACCESSORIES (K901041)Fresenius USA, Inc.1990-06-18
COULTER DIRECT BILIRUBIN (K902199)Coulter Corp.1990-06-12
COULTER SERUM IRON/UIBC REAGENT (K902173)Coulter Corp.1990-06-12
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS (K902095)Phoenix Diagnostics, Inc.1990-06-12
HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) (K902155)Hichem Diagnostics1990-06-12
BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS (K902267)Phoenix Diagnostics, Inc.1990-06-12
COULTER CARBON DIOXIDE REAGENT (K902229)Coulter Corp.1990-06-12
MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST (K901858)E.I. Dupont DE Nemours & Co., Inc.1990-06-12
PROLACTIN (LACTOGEN) TEST SYSTEM (K901673)Baxter Healthcare Corp1990-06-12
COULTER UREA NITROGEN REAGENT (K902175)Coulter Corp.1990-06-12
SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM (K896467)Medisense, Inc.1990-06-12
REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) (K901463)Helena Laboratories1990-06-12
ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) (K902266)Phoenix Diagnostics, Inc.1990-06-06
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406 (K902123)Em Diagnostic Systems, Inc.1990-06-06
BLOOD GAS CONTROLS (K901985)Phoenix Diagnostics, Inc.1990-06-06
IRON REAGENTS PRODUCT CODES 7725 AND 7726 (K901960)American Research Products Co.1990-05-31
DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET (K901988)Casco Standards1990-05-31
BLOOD GAS/CO-OXIMETRY CONTROL (K901976)Phoenix Diagnostics, Inc.1990-05-31
NEOCOAT T4 (K901939)Neometrics, Inc.1990-05-31
PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 (K901964)American Research Products Co.1990-05-31
CO-OXIMETER CONTROLS (K901986)Phoenix Diagnostics, Inc.1990-05-31
ROTAG CONTROLS (K900719)Roche Diagnostic Systems, Inc.1990-05-30
COULTER ALBUMIN REAGENT (K901268)Coulter Corp.1990-05-30
QUICK CHEM II (K901695)Seradyn, Inc.1990-05-24
NIIC MODEL: DX901 ASPIRATION SYSTEM (K900185)Niic U.S.A., Inc.1990-05-24
DSL C-PEPTIDE RIA (DSL #7000) (K896420)Diagnostic Systems Laboratories, Inc.1990-05-24
ROCHE REAGENT FOR MAGNESIUM (K901758)Roche Diagnostic Systems, Inc.1990-05-23
COULTER CK (CREATINE KINASE) REAGENT (K901267)Coulter Corp.1990-05-23
URIC ACID TEST KIT (K901001)Elite Technology, Inc.1990-05-23
MICROPLATE REAGENT DISPENSER (K900599)Denley Instruments, Inc.1990-05-17
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