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Clinical Chemistry

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

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RecordFirmDate
ANALOX LM3 MICRO-STAT ANALYSER (K843082)Analox Instruments , Ltd.1984-10-17
DOUMENT TM LINEARITY TEST STANDARDS (K843947)Casco Standards1984-10-17
DACOS PLUS LYTES OPTION (K843239)Coulter Electronics, Inc.1984-10-17
TRIGLYCERIDE ASSAY KIT GPO-CP (K843536)Diagnostic Chemicals, Ltd. (Usa)1984-10-11
ATAC 2000 (K843059)Turpen Laboratory Systems, Inc.1984-10-11
ENCORE TSH REAGENT (K843395)Hybritech, Inc.1984-10-11
ALBUMIN REAGENT SET (K843831)Livonia Diagnostics, Inc.1984-10-11
ASTRA SYSTEMS AMYLASE REAGENT KIT (K843529)Beckman Instruments, Inc.1984-10-11
DIAGEM DIGITAL BLOOD GLUCOSE MONITOR (K841648)Forward Medical Supplies1984-10-11
C-TERMINAL/MID-MOLECULE PARATHYROID - (K843685)Nichols Institute Diagnostics1984-10-11
RENIN RADIOIMMUNOASSAY TEST KIT (K842966)Serono Diagnostics, Inc.1984-10-11
LIQUID CHROMATOGRAPHY COLUMNS;ION EXCH (K842909)Supelco, Inc.1984-10-05
STANDARDS & ACCESSORIES FOR NOVA INSTRU (K842873)Diagnostic Chemicals, Ltd. (Usa)1984-10-05
BOEHRINGER MANNHEIM DIAGNOSTICS ADAM (K843283)Boehringer Mannheim Corp.1984-10-05
SCLAVO CHLORIDE TEST (K843740)Sclavo, Inc.1984-10-05
ROCHE REAGENT FOR ALT (K843111)Roche Diagnostic Systems, Inc.1984-10-05
ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. (K843434)Iso-Data, Inc.1984-10-05
PERSPECTIVE CHEMICAL ANALYZER (K843610)American Monitor Corp.1984-10-05
KOVA TROL I,II, III HUMAN URINE-DRIED (K843565)Icl Scientific1984-10-05
ENCORE HCG REAGENT (K843407)Hybritech, Inc.1984-10-04
TSH QUIK RIA KIT (K843545)Pacific Biotech, Inc.1984-10-02
EPSILON HCG TEST KIT MONOCLONAL (K842654)Beckman Instruments, Inc.1984-10-01
TOTAL PROTEIN REAGENT SET (K843701)Livonia Diagnostics, Inc.1984-10-01
SYSTEMATE A AMYLASE HEM 67204 (K843645)Em Diagnostic Systems, Inc.1984-09-28
FIAX 420 DILUTOR (K843621)Intl. Diagnostic Technology1984-09-28
ISO-SEP SYSTEM (K842018)Berwick Medical Products, Inc.1984-09-28
VMA ASSAY KIT (K843379)Diagnostic Chemicals, Ltd. (Usa)1984-09-28
PDA GLUCOSE (K843541)Abbott Laboratories1984-09-28
MATCHED COMPONENT SET FOR RADIOIMMUNO- (K843635)Cambridge Medical Technology1984-09-28
TITAN GEL ISO DOT CPK PROCEDURE (K842755)Helena Laboratories1984-09-28
PDA CHOLESTEROL (K843510)Abbott Laboratories1984-09-28
QUALIFY I & II AMER. MONITOR 2009 & 2010 (K843611)American Monitor Corp.1984-09-28
PRECISET AMMONIA (K843569)Boehringer Mannheim Corp.1984-09-28
LEECO CORTISOL-QUANT (K843384)Leeco Diagnostics, Inc.1984-09-28
CREATININE ASSAY KIT (K843377)Diagnostic Chemicals, Ltd. (Usa)1984-09-28
GLUCOSE AUTO& STAT GA-1120 (K843003)Kyoto Diagnostics, Inc.1984-09-28
ENZYMATIC CHOLESTEROL KIT (K843222)Livonia Diagnostics, Inc.1984-09-28
GLUCOSE OXIDASE ENZYMATIC REAGENT SET (K843528)Livonia Diagnostics, Inc.1984-09-28
H.P.T. HOME PREG. TEST KIT & A.P.T. (K834474)Biomedical Research & Development Laboratories, Inc.1984-09-28
ANDROSTENEDIONE BY RIA (K842960)Radioassay Systems Laboratories, Inc.1984-09-27
ISO-DATA IMMUNOASSAY NETWORK SYSTEM (K843365)Iso-Data, Inc.1984-09-27
STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ (K843452)Fisher Scientific Co., LLC1984-09-27
ULTRAVIOLET-VISIBLE SPECTROPHOTOMETER (K843460)Varian Assoc., Inc.1984-09-26
TRIGLYCERIDES GPO REAGENT (K843552)Bio-Rad1984-09-26
ACCUSCREEN TSH (K843281)Neometrics, Inc.1984-09-26
PRECISION DISPENSER (K843606)Medical Technomics, Ltd.1984-09-21
STANBIO QUICK-TELL MONOCLONAL INDIRECT (K842544)Stanbio Laboratory1984-09-21
LABOPETTOR (K843607)Medical Technomics, Ltd.1984-09-21
ACID PHOSPHATASE ASSAY KIT (K843380)Diagnostic Chemicals, Ltd. (Usa)1984-09-20
RAICHEM CALCIUM REAGENT (K843353)Reagents Applications, Inc.1984-09-20
SYSTEMATE GOT 67208 (K843333)Em Diagnostic Systems, Inc.1984-09-20
SYSTEMATE D-BILI 67213 (K843329)Em Diagnostic Systems, Inc.1984-09-20
SYSTEMATE T-BILI 67212 (K843328)Em Diagnostic Systems, Inc.1984-09-20
SYSTEMATE GPT 67209 (K843334)Em Diagnostic Systems, Inc.1984-09-20
STRATUS CORTISOL FLUOROMETRIC ENZYME (K843183)American Dade1984-09-17
DRI-STAT ENZYMATIC BILIRUBIN TEST KIT (K843174)Beckman Instruments, Inc.1984-09-14
CORITSOL PREMIX RIA KIT (K842957)Biotecx Laboratories, Inc.1984-09-14
CORNING HIGH RESOLUTION PROTEIN ELECTRO (K843397)Corning Medical & Scientific1984-09-14
PROLACTIN IRMA (K842478)Euro-Diagnostics BV1984-09-14
SYSTEMATE CHOLESTEROL 67222 (K843327)Em Diagnostic Systems, Inc.1984-09-14
DYNA-LYTE 2000 (K842786)Abbott Diagnostics1984-09-14
ALKALINE PHOSPHATASE REAGENT SET (K843332)Sterling Biochemical, Inc.1984-09-14
SYSTEMATE BUN HEM NO. 67221 (K843326)Em Diagnostic Systems, Inc.1984-09-14
TECHNICON RA-1000 SYS IRON FOR SERUM (K843255)Technicon Instruments Corp.1984-09-14
MACBETH COLOR EIAD 100/100PC (K842770)Macbeth1984-09-14
INORGANIC PHOSPHORUS TEST (K843177)Sclavo, Inc.1984-09-14
ANSWER ONE-DAY (K843238)Armkel, LLC1984-09-14
SYSTEMATE PHOSPHORUS 67217 (K843330)Em Diagnostic Systems, Inc.1984-09-14
MICROBIOLOGICAL TRAY READER-MANUAL (K842947)American Micro Scan1984-09-14
NMS 1043 ENZYME IMMUNOASSAY KIT (K842499)Nms Pharmaceuticals, Inc.1984-09-14
ID ZONE NORMAL LD ISOENZYME CONTROL (K843266)Beckman Instruments, Inc.1984-09-13
ELVI 675 DIGITRON (K843296)Logos Scientific, Inc.1984-09-13
ROCHE STANDARDS FOR URIC ACID (K843112)Roche Diagnostic Systems, Inc.1984-09-13
SYSTEMATE 2GT - 67207 (K843268)Em Diagnostic Systems, Inc.1984-09-13
SYSTEMATE ALKALINE PHOSPHATASE-67203 (K843270)Em Diagnostic Systems, Inc.1984-09-13
SYSTEMATE URIC ACID, HEM 67220 (K843325)Em Diagnostic Systems, Inc.1984-09-13
AXIOM STABLE II TRIGLYCERIDES TEST (K842443)Axiom, Inc.1984-09-13
SYSTEMATE LDH, 67210 (K843269)Em Diagnostic Systems, Inc.1984-09-13
ID ZINE LD ISOENZYME CONTROL ABNORM (K843265)Beckman Instruments, Inc.1984-09-13
SUCROSEP THYROID STIMULATING HORMONE (K842593)Boots-Celltech Diagnostics, Inc.1984-09-12
OXALATE URINE CONTROLS NORMAL & ELEVAT (K842366)Sigma Chemical Co.1984-09-12
ELVI 146 SEROSCAN (K842313)Logos Scientific, Inc.1984-09-10
CARDI-CK EIA TEST KIT CK-MB ISOENZYME (K843007)Intl. Immunoassay Laboratories, Inc.1984-09-07
TOTAL BILIRUBIN TEST (K843178)Sclavo, Inc.1984-09-07
DIATROL BLOOD GLUCOSE TEST SYS (K842684)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-09-07
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT (K842694)Terumo Medical Corp.1984-09-07
ALBUMIN ASSAY KIT (K843104)Diagnostic Chemicals, Ltd. (Usa)1984-09-07
CREATININE TEST (K843179)Sclavo, Inc.1984-09-07
SYSTEMATE CK-TOTAL - 67206 (K843271)Em Diagnostic Systems, Inc.1984-09-07
C-PEP-RIA-100 (K842267)Institut National Des Radioelements1984-09-06
HEMATOLOGY ANALYZER (K842310)Hml Inc/Biotechnology Transfer1984-09-06
CALCITONIN RADIOIMMUNOASSAY KIT (K842907)Nichols Institute Diagnostics1984-09-05
AMERLEX-M FREE T-3 RIA (K842949)Amersham Corp.1984-09-05
QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT (K842692)Quidel Corp.1984-09-05
BILIRUBIN ASSAY KIT - TOTAL (K843032)Diagnostic Chemicals, Ltd. (Usa)1984-09-04
CORNING MAGIC CORTISOL RADIOIMMUNO (K841641)Corning Medical & Scientific1984-09-04
CHEMISTRY CONSOLE (K842401)Biovation, Inc.1984-09-04
VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC (K843230)Ventrex Laboratories, Inc.1984-09-04
BILIRUBIN ASSAY KIT DIRECT (K843027)Diagnostic Chemicals, Ltd. (Usa)1984-09-04
AMERLEX-M TSH RIA (K842948)Amersham Corp.1984-09-04
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