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Clinical Chemistry

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

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RecordFirmDate
MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL) (K853127)Micromedic Systems1985-09-16
REFLOTRON SYSTEM (K852133)Boehringer Mannheim Corp.1985-09-16
MAGNESIUM (K853592)Pointe Scientific, Inc.,1985-09-16
ABSORBANCE TEST SOLUTION (K853533)Diagnostic Systems1985-09-16
DIASCAN CONTROL (K853553)Home Diagnostics, Inc.1985-09-16
QCA ENZYMATIC GLUCOSE (K853656)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-09-16
GLUCOSE SR LIQUID STABLE REAGENT SET (K853464)Medical Analysis Systems, Inc.1985-09-04
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY (K852845)Diagnostic Products Corp.1985-09-04
ACU-SLIDE-TEST (K853247)Cal-Tech Diagnostics, Inc.1985-09-04
HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY (K853006)Modern Diagnostics, Inc.1985-09-04
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER (K853531)American Dade1985-09-04
TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE (K852611)Miles Laboratories, Inc.1985-09-03
SERA-210 ELECTROLYTE ANALYZER (K853356)Horiba Instruments, Inc.1985-09-03
SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV (K850368)Sigma Chemical Co.1985-08-30
HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE (K852867)Hi Chem, Inc.1985-08-29
SYVA SOLID PHASE COLUMNS (K844948)Syva Co.1985-08-29
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT (K851703)Miles Laboratories, Inc.1985-08-23
MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR (K853152)Sherwood Medical Co.1985-08-23
DELTA TROL I & II (K853373)Electro-Nucleonics Laboratories, Inc.1985-08-23
QCA POTASSIUM TEST KIT (K853404)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-08-23
APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN (K853174)Photec Diagnostics, Inc.1985-08-22
CHLORIDE REAGENT (K852169)Pointe Scientific, Inc.,1985-08-21
IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN (K852441)Clinical Data, Inc.1985-08-21
DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA (K851377)Diagnon Corp.1985-08-21
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM (K852481)Em Diagnostic Systems, Inc.1985-08-21
BETA QUIK STAT (K852327)Pacific Biotech, Inc.1985-08-20
URIC ACID REAGENT (K853357)Sigma Diagnostics, Inc.1985-08-19
125I ESTRADIOL DIRECT RADIOIMMUNOASSAY (K853208)Travenol Laboratories, S.A.1985-08-19
YSI MODEL 2372 TOTAL BLOOD LACTATE KIT (K852261)Yellow Springs Instrument Co., Inc.1985-08-15
TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE (K853244)Simmler, Inc.1985-08-12
T-3 RIASSAY (K852537)Ria Diagnostics1985-08-12
TRIGLYCERIDES LCK 124 (K853041)German American Chamber of Commerce, Inc.1985-08-12
VISION POTASSIUM (K850950)Abbott Laboratories1985-08-12
AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI (K852948)Amresco, Inc.1985-08-07
GENESYS GAMMA COUNTER (K851689)Laboratory Technologies, Inc.1985-08-07
DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS (K851618)Home Diagnostics, Inc.1985-08-06
HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 (K853003)Hi Chem, Inc.1985-08-06
TDX CORTISOL (K852927)Abbott Laboratories1985-08-05
1208 BETACORD AND 1208 BETCORD M (K852434)Lkb Instruments, Inc.1985-08-02
ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE (K853049)Simmler, Inc.1985-08-02
UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN (K853102)Diagnostic Chemicals, Ltd. (Usa)1985-08-02
CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ (K853050)Simmler, Inc.1985-08-02
CORTISOL SYSTEM BY EIA (K852939)American Bioclinical, Inc.1985-08-02
SOPHEIA DHEA-SO4 EIA KIT (K852847)Diagnostic Products Corp.1985-08-02
BIOVATION MAX DATA MANAGEMENT SYSTEM (K853026)Biovation, Inc.1985-08-02
DC LIQUITROL LEVEL 1 & 2 (K852753)Diagnostic Chemicals, Ltd. (Usa)1985-08-02
REPLACEMENT REAGENTS FOR SMAC II SYSTEMS (K852306)Methodist Hospital of Memphis1985-08-02
ACCU-CHEK II (K851456)Boehringer Mannheim Corp.1985-08-01
QUIDEL QUEST OVULATION TEST (K852146)Quidel Corp.1985-07-29
COLOR OVULATION TEST (K851445)Nms Pharmaceuticals, Inc.1985-07-29
CHOLESTEROL METHOD (K852863)Catachem, Inc.1985-07-23
AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE (K852752)American Research Products Co.1985-07-23
THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL (K851641)Ortho Diagnostic Systems, Inc.1985-07-23
TDX REA TRIGLYCERIDES (K852556)Abbott Laboratories1985-07-22
AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC (K852844)American Research Products Co.1985-07-22
ALKALINE PHOSPHATASE (K852784)Advanced Biomedical Methods, Inc.1985-07-22
AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT (K852675)Amersham Corp.1985-07-22
QUICK-CHEM CALIBRATION SET (K852260)Seragen Diagnostics, Inc.1985-07-22
IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS (K852676)Allied Instrumentation Laboratory1985-07-22
CEDIA TOTAL T4 ASSAY (K852164)Microgenics Corp.1985-07-22
SGOT/ALT REAGENT (K852783)Advanced Biomedical Methods, Inc.1985-07-22
UROL-GUANT (K852295)Dimension Diagnostics1985-07-22
ISOGEL AGAROSE (K841407)Fmc Corp.1985-07-16
SPINAL FLUID CONTROL (K851820)Irvine Scientific1985-07-15
QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) (K852418)Amf Biological and Diagnostics Co.1985-07-15
AMRESCO CALCIUM REAGENT SET (K852657)American Research Products Co.1985-07-15
VISUAL SERUM/URINE HCG COMBO KIT (K852437)American Bioclinical, Inc.1985-07-12
NML TSH IRMA (K852438)Nuclear Medical Laboratories, Inc.1985-07-12
DC-3 FLUIDS PACK, DC-5 FLUIDS PACK (K852595)Diagnostic Chemicals, Ltd. (Usa)1985-07-12
CHLORIDE ASSAY KIT (K852058)Diagnostic Chemicals, Ltd. (Usa)1985-07-12
X-AMYLASE ASSAY KIT (K852636)Diagnostic Chemicals, Ltd. (Usa)1985-07-12
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA (K852473)Roche Diagnostic Systems, Inc.1985-07-12
HYBRITECH IMMUNOCHEMISTRY ANALYZER (K852385)Hybritech, Inc.1985-07-12
SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 (K852483)Em Diagnostic Systems, Inc.1985-07-12
DATA CHEM IRON PROCEDURE (K852583)Data Medical Associates, Inc.1985-07-12
DUPONT PREP FOUR-SOLVENT RETROFIT KIT (K851393)E.I. Dupont DE Nemours & Co., Inc.1985-07-12
CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET (K852461)Medical Analysis Systems, Inc.1985-07-12
TECHNICON CHEMI (K852565)Technicon Instruments Corp.1985-07-12
DC-LIP, CATALOGUE NUMBER SE-020 (K852594)Diagnostic Chemicals, Ltd. (Usa)1985-07-12
APO B RIA KIT (K851389)Iso-Tex Diagnostics1985-07-10
CHEM PRO 1000 CHEMISTRY ANALYSIS (K851100)Sen Tech Medical Corp.1985-07-09
LEE-BEAD TSH(EIA) (K852224)Lecco Diagnostics, Inc.1985-07-09
SIMULTANEOUS LH/FSH SYSTEM BY RIA (K852376)American Bioclinical, Inc.1985-07-09
TERUMO SENSIBEAD EIA HGH KIT (K852299)Terumo Medical Corp.1985-07-09
CHOLESTEROL TEST SYSTEM (K850390)Hans J. Brouwers & Assoc.1985-07-09
DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST (K852286)Sero-Immuno Diagnostics, Inc.1985-07-09
DADE BLOOD GAS AMPUL INJECTOR (K852285)American Dade1985-07-09
BLHI LUTEINIZING HORMONE (K851332)Euro-Diagnostics BV1985-07-09
BETA HCG EXTENDED RANGE ACCESSORY KIT (K852183)Abbott Laboratories1985-07-09
HDL CHOLESTEROL PRETREATMENT (K852350)American Monitor Corp.1985-07-08
DURAZYME UREA NITROGEN (K852292)American Monitor Corp.1985-07-08
EMIT ANCILLARY REAGENTS (K844947)Syva Co.1985-06-28
ANSWER (K852274)Armkel, LLC1985-06-28
ECHOCLONAL HCG IRMA (K852201)Bio-Rad1985-06-28
SERUM TRANSPORT VIALS, T25/SC, TZ10/SC (K851506)Ncs Diagnostics, Inc.1985-06-27
ALBUMIN (K850931)Dilab, Inc.1985-06-26
BHCG-ROCHE EIA (K850727)Hoffmann-La Roche, Inc.1985-06-25
TANDEM E PAP (K851950)Hybritech, Inc.1985-06-25
CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ (K850907)Cala Diagnostics1985-06-25
ASSIST CLINICAL CHEMISTRY ANALYZER (K852262)Cooper Biomedical, Inc.1985-06-25
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