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Clinical Chemistry

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

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RecordFirmDate
AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT) (K884105)Amersham Corp.1988-11-16
AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 (K881056)American Research Products Co.1988-11-15
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 (K884548)Em Diagnostic Systems, Inc.1988-11-10
PROBE(TM) MODELS 700 AND 1000 (K883749)Packard Instrument Co., Inc.1988-11-10
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL (K883942)Icl Scientific1988-11-10
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 (K884549)Em Diagnostic Systems, Inc.1988-11-10
CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE (K883813)Ciba Corning Diagnostics Corp.1988-11-10
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95 (K884021)Em Diagnostic Systems, Inc.1988-11-10
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 (K884100)Amersham Corp.1988-11-10
MAGNESIUM REAGENT (MAGON SULFONATE) (K883972)Sigma Chemical Co.1988-11-10
HYGEIA URINE PREGNANCY TEST (K882192)Hygeia Sciences1988-11-10
CREATINE KINASE (CK) ISOENZYME MB (K881168)Data Medical Associates, Inc.1988-11-10
DIMENSION WHOLE BLOOD CHOLESTEROL (K880723)Technimed, Inc.1988-11-08
CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY (K883722)Ciba Corning Diagnostics Corp.1988-11-04
CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18 (K880868)Diagnostic Chemicals, Ltd. (Usa)1988-11-01
IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES (K883747)Diagnostic Products Corp.1988-11-01
AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) (K883878)Amersham Corp.1988-11-01
SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER (K883539)Serono-Baker Diagnostics, Inc.1988-10-31
IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) (K883267)Diagnostic Products Corp.1988-10-31
BEHRING TURBITIMER (K883646)Behring Diagnostics, Inc.1988-10-31
ONE-STEP HCG (K882896)Wampole Laboratories1988-10-31
TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE (K883765)Biotecx Laboratories, Inc.1988-10-31
HI CHEM KINETIC CHOLESTEROL REAGENT #88218 (K883844)Hichem Diagnostics1988-10-31
CHEM 1 UIBC (IRON BINDING CAPACITY TEST) (K883104)Technicon Instruments Corp.1988-10-25
ROCHE REAGENT FOR CALCIUM (K883453)Roche Diagnostic Systems, Inc.1988-10-25
OXALATE REAGENT (K883525)Sigma Chemical Co.1988-10-25
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME (K883479)Baxter Healthcare Corp1988-10-25
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II (K882486)Bio-Rad1988-10-25
CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST (K883321)Heraeus Kulzer, Inc.1988-10-25
QLIA T UPTAKE ASSAY (K883971)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-25
DISCOVER(R) (K882232)Carter Products1988-10-25
BILIRUBIN STANDARD (K882059)Verichem Laboratories, Inc.1988-10-25
QM300 APOLIPOPROTEIN B ANTIBODY PACK (K883714)Kallestad Diag, A Div. of Erbamont, Inc.1988-10-19
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK (K883713)Kallestad Diag, A Div. of Erbamont, Inc.1988-10-19
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY (K883927)Ciba Corning Diagnostics Corp.1988-10-13
VISION CREATINE KINASE (K883946)Abbott Laboratories1988-10-13
CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY (K882560)Ciba Corning Diagnostics Corp.1988-10-13
TECHNICON RA(TM) SYSTEMS - MAGNESIUM (K883326)Technicon Instruments Corp.1988-10-13
ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (K883387)Tech-Co, Inc.1988-10-13
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST (K883861)Casco Standards1988-10-13
NOVASPEC II SPECTROPHOTOMETER (K883435)Pharmacia, Inc.1988-10-13
TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS (K883792)Catachem, Inc.1988-10-12
MODIFIED BETA QUIK STAT EIA KIT (K882895)Pacific Biotech, Inc.1988-10-12
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA (K882736)Amersham Corp.1988-10-11
BINAS LUTEINIZING HORMONE IRMA TEST KIT (K883306)Binax, Inc.1988-10-06
BLUE DOT(TM) TEST FOR PREGNANCY (K882588)V-Tech, Inc.1988-10-06
CLEARVIEW HCG (K883777)Unipath , Ltd.1988-10-06
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY (K883305)Binax, Inc.1988-10-06
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190 (K882728)Amersham Corp.1988-10-06
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL (K883147)Utak Laboratories, Inc.1988-10-06
CHLORIDE (K883386)Tech-Co, Inc.1988-10-06
MODIFIED HCG IRMA KIT (K883639)Pacific Biotech, Inc.1988-10-06
QTEST PREGNANCY TEST CONTROL (K883741)Quidel Corp.1988-10-03
DELFIA(TM) NEONATAL HTSH KIT (K881627)Pharmacia, Inc.1988-10-03
CHECK-MM (K883223)Intl. Immunoassay Laboratories, Inc.1988-09-30
RAPIDTEST-HCG (TM) (K883235)Synbiotics Corp.1988-09-30
ISOFOR-MM (TM) (K883222)Intl. Immunoassay Laboratories, Inc.1988-09-30
AMERLITE FREE THYROID CONTROL SERA LAN.4002 (K883124)Amersham Corp.1988-09-30
MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE (K883320)Sherwood Medical Co.1988-09-27
AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT (K882907)Amersham Corp.1988-09-22
QUIDEL PREGNANCY TEST CONTROL (K883316)Quidel Corp.1988-09-22
AVL MODEL 986 ELECTROLYTE ANALYZER (K883240)Avl Scientific Corp.1988-09-22
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE (K883181)Beckman Instruments, Inc.1988-09-19
COULTER VISCOMETER II (K883503)Coulter Electronics, Inc.1988-09-19
ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY (K883395)Quantimetrix Medical Industries1988-09-19
PRL-QUANT (K883269)Leeco Diagnostics, Inc.1988-09-13
DURAZYME(R) CPK (K883504)American Monitor Corp.1988-09-13
IQ HDL CHOLESTEROL (K883353)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-13
URIC ACID REAGENT (PRODUCT #88219) (K883404)Hichem Diagnostics1988-09-13
TRIGLYCERIDES REAGENT (PRODUCT #88218) (K883405)Hichem Diagnostics1988-09-13
VENTREX COATED TUBE TSH (K883342)Ventrex Laboratories, Inc.1988-09-13
TECHNICON RA-100(TM) SYSTEM (K883209)Technicon Instruments Corp.1988-09-13
EMAX PRECISION MICROPLATE READER (K883302)Molecular Devices Corp.1988-09-13
BIOTROL URIC ACID ENZYMATIQUE TRINDER (K883428)Biotrol, USA, Inc.1988-09-13
LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL (K883247)Quantimetrix Medical Industries1988-09-13
PHASE II FSH KIT (K883279)Vitek Systems, Inc.1988-09-09
A.QC CHEMISTRY CONTROL LEVEL 2 (K883012)Arden Medical Systems, Inc.1988-09-09
PREGNAGEN(TM) (K882002)Biogenex Laboratories1988-09-09
ALTLTS ALANINE AMINO TRANSFERASE ALT (K883205)Electro-Nucleonics, Inc.1988-09-09
STAT FAX(TM) (K882938)Awareness Technology, Inc.1988-09-09
BLOOD GAS MIXTURE (K882941)Swisco, Inc.1988-09-09
T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS (K883085)Serono Diagnostics, Inc.1988-09-09
LACTATE DEHYDROGENASE LDH (K883206)Electro-Nucleonics, Inc.1988-09-09
OLYMPUS REPLY CHEMISTRY ANALYZER (K882451)Olympus Corp.1988-09-08
MICROLYTE 7 (K880973)The Rupp & Bowman Co.1988-09-07
TECHNICON DPA-1 APOLIPOPROTEIN B (K883491)Technicon Instruments Corp.1988-09-07
MULTI-CHEMISTRY LINEARITY STANDARD (K875285)Verichem Laboratories, Inc.1988-09-02
RFA-300 RAPID FLOW ANALYZER W/COMPUTER (K883020)Alpkem Corp.1988-09-02
WAKO(TM) AUTOKIT AMYLASE (K883059)Wako Chemicals USA, Inc.1988-08-30
DC-LIQUICAL CATALOGUE #SE-030 (K882258)Diagnostic Chemicals, Ltd. (Usa)1988-08-30
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES (K882741)Nichols Institute Diagnostics1988-08-30
DART CARBON DIOXIDE (K883055)Coulter Electronics, Inc.1988-08-30
DTR ANALYZER (K882913)Abbott Laboratories1988-08-30
VISTA INSTRUMENT (K882914)Abbott Laboratories1988-08-30
FIAGEN HGH FLUOROIMMUNOASSAY KIT (K882823)Cyberfluor, Inc.1988-08-30
LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD (K881868)Supelco, Inc.1988-08-29
FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT (K881015)Pacific Biotech, Inc.1988-08-29
LAD MODEL 633 LUMINOMETER (K882608)Los Alamos Diagnostics1988-08-29
RAICHEM(TM) BILIRUBIN STANDARD (K882726)Reagents Applications, Inc.1988-08-29
DADE(R) CK-MB IMMUNOASSAY CONTROL (K882795)Baxter Healthcare Corp1988-08-29
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