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Clinical Chemistry

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

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RecordFirmDate
CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN (K885144)Heraeus Kulzer, Inc.1989-02-02
CLINISTAT SGOT (AST) REAGENT TEST (K885156)Heraeus Kulzer, Inc.1989-02-02
SOURCERER (K884091)John Caunt Scientific , Ltd.1989-02-02
MODEL 250 LIQUID CHROMOTAGRAPHY PUMP (K884886)The Perkin-Elmer Corp.1989-02-02
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661 (K884546)Em Diagnostic Systems, Inc.1989-02-02
PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY (K884794)Serono-Baker Diagnostics, Inc.1989-02-02
GLUCOSE-SUPER FAST 4983050 AND 4983500 (K882262)American Research Products Co.1989-02-02
BIOTROL URINE PROTEINS REAGENT (K885053)Biotrol, USA, Inc.1989-01-30
PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST (K883430)Disease Detection International, Inc.1989-01-30
TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) (K884748)Technicon Instruments Corp.1989-01-30
TOTAL BILIRUBIN TEST CATALOG NO. SR1007 (K885284)Em Diagnostic Systems, Inc.1989-01-30
BIOTROL INORGANIC PHOSPHORUS (K885041)Biotrol, USA, Inc.1989-01-30
DIRECT BILIRUBIN TEST CATALOG NO. SR1008 (K885285)Em Diagnostic Systems, Inc.1989-01-30
TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) (K884747)Technicon Instruments Corp.1989-01-30
LIPOCLEAR LIPEMIA CLEARING REAGENT (K884807)Statspin Technologies1989-01-27
TECHNICON RA-100 SYSTEM CALCIUM METHOD (K884599)Technicon Instruments Corp.1989-01-27
GAS TRAK PLUS (K884977)United Diagnostics, Inc.1989-01-27
TARGET READER (K885254)V-Tech, Inc.1989-01-27
TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE (K884601)Technicon Instruments Corp.1989-01-27
BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD (K883967)Beckman Instruments, Inc.1989-01-27
ANALYST THYROXINE (T4) ROTOR (K884700)The DU Pont Co.1989-01-27
UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON. (K871115)Labo Science-USA, Inc.1989-01-27
DU PONT ANALYST THYROID ROTOR (K884169)The DU Pont Co.1989-01-24
URIC ACID TEST (URIC) ITEM #65620 (K884704)Em Diagnostic Systems, Inc.1989-01-23
CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST (K883327)Heraeus Kulzer, Inc.1989-01-23
TOTAL PROTEIN TEST (TP) ITEM #65670 (K884703)Em Diagnostic Systems, Inc.1989-01-23
ALBUWELL (K884146)Exocell, Inc.1989-01-23
TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM (K884600)Technicon Instruments Corp.1989-01-23
FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT (K884708)Cyberfluor, Inc.1989-01-17
MAGNESIUM TEST ITEM NUMBER: SR1019 (K885022)Em Diagnostic Systems, Inc.1989-01-17
MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY (K884769)Ciba Corning Diagnostics Corp.1989-01-17
CALCIUM TEST ITEM NUMBER: SR1009 (K884986)Em Diagnostic Systems, Inc.1989-01-13
ELECTR-TRANSBLOTTER (K882344)The W.E.P. Co.1989-01-13
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022 (K884987)Em Diagnostic Systems, Inc.1989-01-13
GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664 (K884988)Em Diagnostic Systems, Inc.1989-01-13
FIRSTDAY EARLY PREGNANCY TESTING KIT II (K884616)Pacific Biotech, Inc.1989-01-13
CLINISTAT GLUCOSE REAGENT TEST (K884756)Heraeus Kulzer, Inc.1989-01-13
PREGNAGEN(TM) (K884880)Biogenex Laboratories1989-01-13
CHLORIDE TEST (CL) ITEM #65659 (K884706)Em Diagnostic Systems, Inc.1989-01-11
AMYLASE TEST (AMYL) ITEM NUMBER: 65653 (K884382)Em Diagnostic Systems, Inc.1989-01-11
ALBUMIN TEST (ALB) ITEM #65650 (K884705)Em Diagnostic Systems, Inc.1989-01-11
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC) (K884189)Eastman Kodak Company1989-01-11
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652 (K884376)Em Diagnostic Systems, Inc.1989-01-11
SAMPLE IDENTIFICATION STATION MODEL 38010 (K884269)Icn Micromedic Systems1989-01-09
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665 (K884736)Em Diagnostic Systems, Inc.1989-01-03
AUTOMATED EIA READER MODEL EL311 (K884124)Bio-Tek Instruments, Inc.1989-01-03
MODIFIED TSH IRMA KIT (K883742)Pacific Biotech, Inc.1989-01-03
-AMYLASE EPS (K882225)Boehringer Mannheim Corp.1989-01-03
ALANINE AMINOTRANSFERASE (K884936)Catachem, Inc.1989-01-03
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L (K884909)American Research Products Co.1989-01-03
VIRGO(R) MICROWELL ALT ASSAY (K884784)Electro-Nucleonics, Inc.1988-12-29
VISUAL BLOOD GLUCOSE TEST SYSTEM (K884993)Diagnostic Systems1988-12-29
SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER (K884035)Sclavo, Inc.1988-12-29
ABBOTT SPECTRUM(R) BICARBONATE REAGENT (K884821)Abbott Laboratories1988-12-27
COTUBE LH IRMA ASSAY (K884498)Bio-Rad1988-12-22
LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE (K884403)Supelco, Inc.1988-12-22
AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT (K883123)Amersham Corp.1988-12-22
CREATININE TEST (CREA) ITEM #65663 (K884734)Em Diagnostic Systems, Inc.1988-12-19
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST (K883530)Tambrands, Inc.1988-12-19
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE) (K884355)Eastman Kodak Company1988-12-16
LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 (K883615)Supelco, Inc.1988-12-16
PHOSPHORUS TEST (PHOS) ITEM #65666 (K884735)Em Diagnostic Systems, Inc.1988-12-16
HDL-CHOLESTEROL PRECIPITATING REAGENT (K883543)Medical Analysis Systems, Inc.1988-12-16
TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS (K884224)A-Kem, Inc.1988-12-15
ABC FP ANALYZER (K883533)Intl. Bioclinical, Inc.1988-12-15
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) (K884424)Bio-Rad1988-12-15
UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS (K884693)Biomedical Research & Development Laboratories, Inc.1988-12-15
THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL (K883726)Immuchem Corp.1988-12-15
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654 (K884377)Em Diagnostic Systems, Inc.1988-12-14
TOTAL IRON BINDING CAPACITY TEST (K884649)Sclavo, Inc.1988-12-14
PUMPETTE(TM) (K884111)Helena Laboratories1988-12-14
DELFIA THYROXINE (T4) KIT (K883559)Pharmacia, Inc.1988-12-14
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD (K883389)Reagents Applications, Inc.1988-12-14
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET (K884197)Casco Standards1988-12-14
FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT (K884201)Cyberfluor, Inc.1988-12-14
SERUM HCG MICROASSAY (K884430)Diamedix Corp.1988-12-09
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM (K883817)Boehringer Mannheim Corp.1988-12-09
AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (K884226)A-Kem, Inc.1988-12-09
TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS (K884225)A-Kem, Inc.1988-12-09
MODIFIED CEDIA TOTAL T4 ASSAY (K884634)Microgenics Corp.1988-12-09
ROCHE REAGENT FOR CHLORIDE (K884013)Roche Diagnostic Systems, Inc.1988-12-09
IDS-1600 SAMPLE HANDLING SYSTEM (K883470)Baxter Healthcare Corp1988-12-09
CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM (K884227)A-Kem, Inc.1988-12-09
ABBOTT A-GENT LIPASE REAGENT (K884596)Abbott Laboratories1988-12-06
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY (K884687)Ciba Corning Diagnostics Corp.1988-12-06
IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40 (K883148)Diagnostic Chemicals, Ltd. (Usa)1988-12-05
RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO (K884207)Abbott Laboratories1988-12-02
NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER (K884143)Nova Biomedical Corp.1988-12-02
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY (K884085)Hybritech, Inc.1988-12-02
VISION LYTE (TM) POTASSIUM (K884566)Abbott Laboratories1988-12-02
DELFIA TRIIODOTHYRONINE (T3) KIT (K883810)Pharmacia, Inc.1988-12-02
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES (K883745)Diagnostic Products Corp.1988-11-30
TECHNICON RA-100 SYSTEM POTASSIUM (K883586)Technicon Instruments Corp.1988-11-29
BIOTROL BILIRUBIN MONOREACTIF (K884480)Biotrol, USA, Inc.1988-11-29
HOME CLINIC PREGNANCY TEST (K883826)Vanguard Biomedical Corp.1988-11-29
TECHNICON ASSIST POTASSIUM (K883585)Technicon Instruments Corp.1988-11-29
ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. (K884168)The DU Pont Co.1988-11-29
ROCHE REAGENT FOR INORGANIC PHOSPHORUS (K883962)Roche Diagnostic Systems, Inc.1988-11-29
ABBOTT IMX LH (K884138)Abbott Laboratories1988-11-29
TECHNICON ASSIST(R) CALCIUM METHOD (K884433)Technicon Instruments Corp.1988-11-29
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