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Clinical Chemistry

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

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RecordFirmDate
MG REAGENT (K852005)Alpkem Corp.1985-06-25
PHOSPHORUS (K850934)Dilab, Inc.1985-06-25
INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU (K851990)Alpkem Corp.1985-06-25
ELECTROLYTE ANALYZER (K851808)Ionetics, Inc.1985-06-25
CA BUFFER CA DYE (K852002)Alpkem Corp.1985-06-25
PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES (K844894)Slt Labinstruments, Inc.1985-06-25
CREATININE (K850932)Dilab, Inc.1985-06-25
PREGNANCY CARD TEST (K852066)Em Diagnostic Systems, Inc.1985-06-25
URIC ACID (K850933)Dilab, Inc.1985-06-25
CHOLESTEROL (K850938)Dilab, Inc.1985-06-25
TOTAL PROTEINS (K850936)Dilab, Inc.1985-06-25
CK/LD ISOENZYMES CONTROLS(HUMAN) (K851520)Seragen Diagnostics, Inc.1985-06-25
VENTREZYME ALLERGEN DATA REDUCTION SYSTEM (K851403)Ventrex Laboratories, Inc.1985-06-21
CORNING CERTAIN -ISE (K851939)Corning Medical & Scientific1985-06-14
MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA (K851329)Corning Medical & Scientific1985-06-13
AMY REAGENT (K852001)Alpkem Corp.1985-06-10
UREA (K850937)Dilab, Inc.1985-06-10
BUN(ENDPOINT) REAGENT (K852131)Sigma Diagnostics, Inc.1985-06-10
GLUCOSE(TRINDER) REAGENT (K852130)Sigma Diagnostics, Inc.1985-06-10
GLUCOSE (K850930)Dilab, Inc.1985-06-10
CHLORIDE (K850935)Dilab, Inc.1985-06-10
TP BIURET REAGENT (K852006)Alpkem Corp.1985-06-10
SERUM IRON/VIBC REAGENT SET (K852161)Livonia Diagnostics, Inc.1985-06-10
CALCIUM (K850929)Dilab, Inc.1985-06-10
G-GT REAGENT (K851999)Alpkem Corp.1985-06-10
CLINICAL CHEMISTRY ANALYTICAL SYSTEM (K851933)Allied Instrumentation Laboratory1985-06-10
SOMATOMEDIN C BY RADIOIMMUNOASSAY (K850892)Immuno Nuclear Corp.1985-06-06
ESTRADIOL DIRECT RIA KIT (K851540)Biotecx Laboratories, Inc.1985-06-06
AST ASPARTATE AMINOTRANSFERASE REAGENT (K851994)Alpkem Corp.1985-06-03
IP ACID REAGENT IP MOLY BDATE REAGENT (K852003)Alpkem Corp.1985-05-31
SC-360 SPECTROPHOTOMETER (K852047)Pharmacia, Inc.1985-05-31
DELFIA HTSH KIT (K851120)Lkb Instruments, Inc.1985-05-31
ENDAB TSH (K851980)Immunotech Corp.1985-05-31
LD-L REAGENT (K851996)Alpkem Corp.1985-05-31
INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN (K852103)Medical Analysis Systems, Inc.1985-05-31
TOTAL BILIRUBIN STANDARDS (K852068)Data Medical Associates, Inc.1985-05-31
COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY (K851942)Coulter Electronics, Inc.1985-05-31
DIRECT BILIRUBEN CALIBRATIONS (K852067)Data Medical Associates, Inc.1985-05-31
LD-P REAGENT (K851997)Alpkem Corp.1985-05-30
ALB BCG REAGENT (K852007)Alpkem Corp.1985-05-30
CRE BUFFER CRE DYE (K851993)Alpkem Corp.1985-05-30
T-CHO REAGENT (K852009)Alpkem Corp.1985-05-30
CK-NAC REAGENT (K852000)Alpkem Corp.1985-05-30
TGL REAGENT (K852010)Alpkem Corp.1985-05-30
ALT (ALANINE AMINO-THRANSFERASE)REAGENT (K851995)Alpkem Corp.1985-05-30
ALP(ALKALINE)(PHOSPHATASE) REAGENT (K851998)Alpkem Corp.1985-05-30
T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL (K852008)Alpkem Corp.1985-05-30
UN(UREASE)REAGENT UN(A-KETO)REAGENT (K851991)Alpkem Corp.1985-05-29
UA(URICASE) REAGENT (K852004)Alpkem Corp.1985-05-29
GLU(GOD) REAGENT (K851992)Alpkem Corp.1985-05-29
LKB-WALLAC 1230 ARCUS FLUOROMETER (K851984)Lkb Instruments, Inc.1985-05-24
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE (K851923)Amresco, Inc.1985-05-24
TDX REA IRON/TIBC (K851930)Abbott Laboratories1985-05-24
OB-PH - PH TEST PAPER (K850858)Uro Pharmaceuticals, Inc.1985-05-24
VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM (K851945)Varian Assoc., Inc.1985-05-24
ULTRA-VIOLET GLUCOSE REAGENT (K851514)Bio-Analytics Laboratories, Inc.1985-05-20
ELVI 655 FLAME PHOTOMETER (K843375)Logos Scientific, Inc.1985-05-20
TRIGLYCERIDE(TRINDER) PROCEDURE (K851538)Data Medical Associates, Inc.1985-05-20
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE (K851865)Amresco, Inc.1985-05-20
CREATINE LIQUID STABLE REAGENT SET (K851849)Medical Analysis Systems, Inc.1985-05-20
FISHER DIAGNOSTICS KDA CALIBRATOR II (K851151)Fisher Scientific Co., LLC1985-05-20
NOVASPEC VISIBLE SPECTROPHOTOMETER (K851572)Lkb Instruments, Inc.1985-05-20
ULTRA-VIOLET BUN REAGENT KIT (K851513)Bio-Analytics Laboratories, Inc.1985-05-20
MULTI FUNCTION BLOOD GAS CONTROL (K851911)Bionostics, Inc.1985-05-20
FISHER DIAGNOSTICS KDA CALIBRATOR I (K851150)Fisher Scientific Co., LLC1985-05-20
TDX TOTAL T3 (K851676)Abbott Laboratories1985-05-20
TOTAL PROTEIN LIQUID STABLE REAGENT SET (K851877)Medical Analysis Systems, Inc.1985-05-20
LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS (K850638)Behring Diagnostics, Inc.1985-05-15
GEN PROFILER SYSTEM (K851619)Electro-Cucleonics, Inc.1985-05-14
CLINALYZER MODEL VX-1000 (K851638)Alpkem Corp.1985-05-13
ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 (K851154)Astral Medical Systems1985-05-13
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT (K851259)Nichols Institute Diagnostics1985-05-13
CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/ (K851670)Medical Analysis Systems, Inc.1985-05-10
SPECTRA 1 FILTER PHOTOMETER (K850994)Awareness Technology, Inc.1985-05-10
RFA-300 RAPID FLOW ANALYZER W/COMPUTER (K851542)Alpkem Corp.1985-05-10
LD-1(IMMUNO) SEPARATION SET (K851521)Seragen Diagnostics, Inc.1985-05-10
UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST (K851076)United Biotech, Inc.1985-05-10
DEMAND MAGNESIUM (K851657)Cooper Biomedical, Inc.1985-05-10
SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P (K850995)Awareness Technology, Inc.1985-05-10
COBAS CALIBRATOR SERUM (K850859)Roche Diagnostic Systems, Inc.1985-05-10
SANDARE IRON-BINDING CAPACITY PROCEDURE (K851395)Sandare Chemical Co., Inc.1985-05-07
AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM (K851361)Amersham Corp.1985-05-07
SMART ALEX II MULTI-FILTER PHOTOMETER (K850993)Awareness Technology, Inc.1985-05-07
COBAS MIRA (K851172)Roche Diagnostic Systems, Inc.1985-05-02
PREGNA-ZYME (K850992)Armkel, LLC1985-05-01
TDX ANALYZER W/NEPHELOMETRY CAROUSEL (K851253)Abbott Laboratories1985-04-30
SANDARE IRON PROCEDURE (K851394)Sandare Chemical Co., Inc.1985-04-30
PROLACTIN SYSTEM BY RIA (K851330)American Bioclinical, Inc.1985-04-29
TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE (K851148)Euro-Diagnostics BV1985-04-29
DSL PAP RIA -DSL#3100 (K844679)Diagnostic Systems Laboratories, Inc.1985-04-29
A-JUST TURBIDITY METER (K851234)Abbott Laboratories1985-04-29
ION 2 REAGENT KI (K851350)Hi Chem, Inc.1985-04-29
SUGAR-CHEX II (K851043)Streck Laboratories, Inc.1985-04-29
GEMENI AST-LTS REAGENTS (K851267)Electro-Nucleonics Laboratories, Inc.1985-04-29
PTH-RIA (K844735)Syncor Intl. Corp.1985-04-29
SUGAR-CHEX (K851042)Streck Laboratories, Inc.1985-04-29
ACTIVE DHEA-SULFATE DSL3500 (K851239)Diagnostic Systems Laboratories, Inc.1985-04-25
BEHRING VECTOR PHOTOMETER (K851098)Behring Diagnostics, Inc.1985-04-25
ATAC 2000 CHEMISTRY ANALYZER (K851321)Turpen Laboratory Systems, Inc.1985-04-25
ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS (K850360)Text Tech Corp.1985-04-17
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