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Clinical Chemistry

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

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RecordFirmDate
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM (K930979)Boehringer Mannheim Corp.1993-09-08
BECKMAN VIGIL PLUS CONTROL (K930850)Beckman Instruments, Inc.1993-09-01
OLYMPUS REPLY GLUCOSE REAGENT (K931744)Olympus Corp.1993-08-31
TRI-TECH INC. CUSTOM BLOOD ALCOHOL (K922342)Tri-Tech, Inc.1993-08-27
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (K933426)Baxter Diagnostics, Inc.1993-08-26
RADIAS B12 ENZYME IMMUNOASSAY (K933315)Bio-Rad1993-08-25
TRIGLYCERIDES (K931891)Em Diagnostic Systems, Inc.1993-08-25
KING SODIUM/POTASSIUM STANDARD MODIFIED (K931834)King Diagnostics, Inc.1993-08-25
ACE CLINICAL CHEMISTRY SYSTEM (K930104)Schiapparelli Biosystems, Inc.1993-08-23
CIBA CORNING 300 SERIES SYSTEM (K933373)Ciba Corning Diagnostics Corp.1993-08-19
SILYL AMYL (K931583)Em Diagnostic Systems, Inc.1993-08-19
OMNI (K925625)Bio-Tek Instruments, Inc.1993-08-19
OLYMPUS REPLY UREA NITROGEN REAGENT (K931745)Olympus Corp.1993-08-19
SIA THYROID STIMULATING HORMONE ELISA KIT (K930050)Sigma Chemical Co.1993-08-19
DC-LINEATE CAT. NO. SE-091 (K932555)Diagnostic Chemicals, Ltd. (Usa)1993-08-19
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM (K932674)Miles Inc., Dental Products1993-08-19
ETHYLIDENE AMYL (K931582)Em Diagnostic Systems, Inc.1993-08-19
COBAS CORE PROLACTIN EIA (K930305)Roche Diagnostic Systems, Inc.1993-08-19
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) (K931773)King Diagnostics, Inc.1993-08-16
IMMULITE FREE T4 (K931704)Diagnostic Products Corp.1993-08-16
COTUBE ESTRADIOL RADIOIMMUNOASSAY (K931740)Bio-Rad1993-08-16
IMMULITE TSH THIRD GENERATION CONTROL (K930007)Diagnostic Products Corp.1993-08-16
APO A-1 CHEMILUMINESCENCE ASSAY (K931777)Nichols Institute1993-08-16
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 (K933317)Bio-Rad1993-08-11
ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP (K922136)Home Diagnostics, Inc.1993-08-10
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP (K922137)Home Diagnostics, Inc.1993-08-10
DU PONT ACA NEV/EEV VERIFIER (K930501)Dupont Medical Products1993-08-09
DADE(R) TUMOR MARKER CONTROL (K924919)Baxter Diagnostics, Inc.1993-08-05
CENTRICON -50 CONCENTRATOR (K930168)Amicon, Inc.1993-08-05
DELFIA TESTTOSTERONE KIT (K932951)Wallac OY1993-08-03
MARKSMAN ARTERIAL BLOOD GAS SYRINGE (K931924)Martech Medical Products, Inc.1993-08-03
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS) (K932729)Eastman Kodak Company1993-08-03
BICARBONATE (K931887)Em Diagnostic Systems, Inc.1993-08-03
REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 (K930317)Helena Laboratories1993-08-03
CIBA CORNING ACS PROGESTERONE IMMUNOASSAY (K932955)Ciba Corning Diagnostics Corp.1993-08-02
DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET (K932870)Casco Standards1993-08-02
TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3 (K931366)Medical Analysis Systems, Inc.1993-07-28
CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3 (K932658)More Diagnostics1993-07-28
ACCUTEX BETA-HCG TEST (K926112)J.S. Medical Assoc.1993-07-28
TRIGLYCERIDES GPO-PAP (K923508)Randox Laboratories, Ltd.1993-07-28
MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM (K932659)More Diagnostics1993-07-28
DELFIA CORTISOL KIT (K930732)Wallac OY1993-07-27
CREATINE KINASE TEST (K931889)Em Diagnostic Systems, Inc.1993-07-27
TOTAL BILIRUBIN (K931888)Em Diagnostic Systems, Inc.1993-07-27
VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT (K931031)Biomerieux Vitek, Inc.1993-07-27
CHEMILUMINESCENCE DHEA-S IMMUNOASSAY (K931601)Nichols Institute1993-07-27
DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD (K932044)Dupont Medical Products1993-07-27
ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT (K926396)Nichols Institute1993-07-27
IQ TUPTAKE ASSAY (K931294)Becton Dickinson Advanced Diagnostics1993-07-22
GLUCOSE-HK TEST (K931890)Em Diagnostic Systems, Inc.1993-07-22
URIC ACID ENZYMATIC COLORIMERIC KIT (K923503)Randox Laboratories, Ltd.1993-07-22
IQ TT4 ASSAY (K931295)Becton Dickinson Advanced Diagnostics1993-07-20
LIQUID AMYLASE REAGENT SET (K930475)Pointe Scientific, Inc.,1993-07-19
MODEL 3D3 OSMOMETER (K925970)Advanced Instruments, Inc.1993-07-09
SYSTEMATE CREATININE TEST ITEM NUMBER 65413 (K932160)Em Diagnostic Systems, Inc.1993-07-09
OPUS(R) TOTAL B-HCG TEST SYSTEM (K932279)Pb Diagnostic Systems, Inc.1993-07-08
ROCHE CARDIOTROL-CK (K930889)Roche Diagnostic Systems, Inc.1993-07-06
SAS(TM) SERUM/URINE HCG (K932409)Sa Scientific, Inc.1993-06-29
DIRECT BILIRUBIN (K930679)Horizon Diagnostics, Inc.1993-06-29
DOCUMENT ENZYME (K932458)Casco Standards1993-06-29
QUICKVUE ONE-STEP HCG COMBO (K932042)Quidel Corp.1993-06-29
CANNABINOID URINE CONTROLS (K932113)Diagnostic Reagents, Inc.1993-06-29
LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II (K932076)Bio-Rad1993-06-29
MULTITROL IMMUNOLOGY CONTROL (K923663)Behring Diagnostics, Inc.1993-06-28
GLUCOMETER M+ BLOOD GLUCOSE METER (K931310)Heraeus Kulzer, Inc.1993-06-25
REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM (K922646)Behring Diagnostics, Inc.1993-06-25
QUANTIMETRIX C-CLEAR(TM) (K931523)Quantimetrix Corp.1993-06-25
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER (K926361)Heraeus Kulzer, Inc.1993-06-24
QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) (K931761)Quidel Corp.1993-06-22
RADIAS TSH ENZYME IMMUNOASSAY (K931061)Bio-Rad1993-06-16
ABBOTT IMX2 ANALYER (K931970)Abbott Laboratories1993-06-16
ACCESS(R) THYROXINE ASSAY (K926475)Bio-Rad Laboratories, Inc.1993-06-15
COAT-A-COUNT INTACT PTH IRMA (K930008)Diagnostic Products Corp.1993-06-15
CHEMSTRIP URINE ANALYZER (K931602)Boehringer Mannheim Corp.1993-06-15
TES-TAPE (K922207)Lilly Research Laboratories1993-06-15
PRO-STEP PT HCG (K925303)Disease Detection International, Inc.1993-06-15
KING DIAGNOSTICS CK REAGENT (K931326)King Diagnostics, Inc.1993-06-15
ANALYZER: STAT PROFILE PLUS 10 ANALYZER (K931373)Nova Biomedical Corp.1993-06-15
IMX(R) STAT CK-MB (K931172)Abbott Laboratories1993-06-15
MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM (K931148)Esa, Inc.1993-06-09
SAS PREGNANCY STRIP (K931302)Sa Scientific, Inc.1993-06-09
UC QIK PREGNANCY TEST (K926500)Eucardio Laboratory, Inc.1993-06-07
OPUS MAGNUM ANALYZER (K926131)Pb Diagnostic Systems, Inc.1993-06-07
ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR (K930477)Analytical Control Systems, Inc.1993-06-07
ACCESS THYROID UPTAKE ASSAY (K930010)Bio-Rad Laboratories, Inc.1993-06-07
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY (K926394)Syva Co.1993-05-26
CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC (K931188)Cascade Medical, Inc.1993-05-26
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT (K931493)Eastman Kodak Company1993-05-26
COBAS CORE LH EIA (K930306)Roche Diagnostic Systems, Inc.1993-05-26
BIOTROL AMYLASE CNPG3 (K931141)Biotrol, USA, Inc.1993-05-26
ACCESS(R) CORTISOL REAGENTS (K926322)Bio-Rad Laboratories, Inc.1993-05-26
RADIAS FREE T4 ENZYME IMMUNOASSAY (K931110)Bio-Rad1993-05-20
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS (K926443)Roche Diagnostic Systems, Inc.1993-05-20
AIA-PACK IGE CALIBRATION VERIFICATION TEST SET (K924859)Tosoh Medics, Inc.1993-05-14
VIDAS THYROXINE (T4) ASSAY (T4) (K926393)Biomerieux Vitek, Inc.1993-05-13
AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS (K930489)E.I. Dupont DE Nemours & Co., Inc.1993-05-12
DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET (K931139)Casco Standards1993-05-12
VACUTAINER BRAND LUER ADAPTER (K931367)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-05-11
IL TEST PHOSPHORUS (K931361)Instrumentation Laboratory CO1993-05-11
CHEK-STIX CONTROL STRIPS FOR URINALYSIS (K931467)Heraeus Kulzer, Inc.1993-05-11
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