meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
57
Latest Decision
1993-09-21

Clearances · page 57 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K930304 COBAS CORE FSH EIA Roche Diagnostic Systems, Inc. CGJ Class I 1993-09-21
K932159 SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 Em Diagnostic Systems, Inc. CIG Class II 1993-09-21
K932528 OLYMPUS CHLORID REAGENT, MODIFIED Olympus Corp. CHJ Class II 1993-09-17
K931997 HCG MIDSTREAM PREGNANCY TEST Mizuho USA, Inc. LCX Class II 1993-09-10
K930006 AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT Bio-Chem Laboratory Systems, Inc. JLW Class II 1993-09-09
K932871 UIBC FOR DISCREET RANDOM ACCESS ANALYZER Catachem, Inc. CFM Class I 1993-09-08
K933675 OPUS TOTAL CK Pb Diagnostic Systems, Inc. CGS Class II 1993-09-08
K926360 GLUCOFILM TEST STRIPS Heraeus Kulzer, Inc. CGA Class II 1993-09-08
K932161 UREA NITROGEN TEST ITEM NUMBER 65408 Em Diagnostic Systems, Inc. CDQ Class II 1993-09-08
K930979 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM Boehringer Mannheim Corp. CGA Class II 1993-09-08
K931835 OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT Olympus Corp. CEO Class I 1993-09-08
K931958 SYNERMED GGT REAGENT KIT Synermed, Inc. JQB Class I 1993-09-08
K931986 AMP ALKALINE PHOSPHATASE REAGENT KIT Synermed, Inc. CJE Class II 1993-09-08
K933066 OPUS ESTRADIOL Pb Diagnostic Systems, Inc. CHP Class I 1993-09-08
K931600 CHEMILUMINESCENCE FREE T3 IMMUNOASSAY Nichols Institute CDP Class II 1993-09-08
K930850 BECKMAN VIGIL PLUS CONTROL Beckman Instruments, Inc. JJY Class I 1993-09-01
K931744 OLYMPUS REPLY GLUCOSE REAGENT Olympus Corp. JJE Class I 1993-08-31
K922342 TRI-TECH INC. CUSTOM BLOOD ALCOHOL Tri-Tech, Inc. JKA Class II 1993-08-27
K933426 STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO Baxter Diagnostics, Inc. CDX Class II 1993-08-26
K931891 TRIGLYCERIDES Em Diagnostic Systems, Inc. CDT Class I 1993-08-25
K933315 RADIAS B12 ENZYME IMMUNOASSAY Bio-Rad CDD Class II 1993-08-25
K931834 KING SODIUM/POTASSIUM STANDARD MODIFIED King Diagnostics, Inc. JIS Class II 1993-08-25
K930104 ACE CLINICAL CHEMISTRY SYSTEM Schiapparelli Biosystems, Inc. JIX Class II 1993-08-23
K925625 OMNI Bio-Tek Instruments, Inc. JJQ Class I 1993-08-19
K930050 SIA THYROID STIMULATING HORMONE ELISA KIT Sigma Chemical Co. JLW Class II 1993-08-19
K930305 COBAS CORE PROLACTIN EIA Roche Diagnostic Systems, Inc. CFT Class I 1993-08-19
K932674 CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM Miles Inc., Dental Products KQO Class I 1993-08-19
K931745 OLYMPUS REPLY UREA NITROGEN REAGENT Olympus Corp. CDQ Class II 1993-08-19
K931583 SILYL AMYL Em Diagnostic Systems, Inc. JFJ Class II 1993-08-19
K932555 DC-LINEATE CAT. NO. SE-091 Diagnostic Chemicals, Ltd. (Usa) JIS Class II 1993-08-19
K933373 CIBA CORNING 300 SERIES SYSTEM Ciba Corning Diagnostics Corp. JGS Class II 1993-08-19
K931582 ETHYLIDENE AMYL Em Diagnostic Systems, Inc. JFJ Class II 1993-08-19
K931773 HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) King Diagnostics, Inc. LBR Class I 1993-08-16
K931777 APO A-1 CHEMILUMINESCENCE ASSAY Nichols Institute MSJ Class I 1993-08-16
K931740 COTUBE ESTRADIOL RADIOIMMUNOASSAY Bio-Rad CHP Class I 1993-08-16
K930007 IMMULITE TSH THIRD GENERATION CONTROL Diagnostic Products Corp. JJX Class I 1993-08-16
K931704 IMMULITE FREE T4 Diagnostic Products Corp. CEC Class II 1993-08-16
K933317 LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 Bio-Rad JJY Class I 1993-08-11
K922136 ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP Home Diagnostics, Inc. CGA Class II 1993-08-10
K922137 DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP Home Diagnostics, Inc. CGA Class II 1993-08-10
K930501 DU PONT ACA NEV/EEV VERIFIER Dupont Medical Products JIS Class II 1993-08-09
K924919 DADE(R) TUMOR MARKER CONTROL Baxter Diagnostics, Inc. JJY Class I 1993-08-05
K930168 CENTRICON -50 CONCENTRATOR Amicon, Inc. JJH Class I 1993-08-05
K931924 MARKSMAN ARTERIAL BLOOD GAS SYRINGE Martech Medical Products, Inc. JKA Class II 1993-08-03
K930317 REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 Helena Laboratories CEF Class I 1993-08-03
K932729 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS) Eastman Kodak Company CEO Class I 1993-08-03
K931887 BICARBONATE Em Diagnostic Systems, Inc. KHS Class II 1993-08-03
K932951 DELFIA TESTTOSTERONE KIT Wallac OY CDZ Class I 1993-08-03
K932870 DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET Casco Standards JJX Class I 1993-08-02
K932955 CIBA CORNING ACS PROGESTERONE IMMUNOASSAY Ciba Corning Diagnostics Corp. JLS Class I 1993-08-02
K923508 TRIGLYCERIDES GPO-PAP Randox Laboratories, Ltd. CDT Class I 1993-07-28
K932658 CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3 More Diagnostics JJX Class I 1993-07-28
K931366 TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3 Medical Analysis Systems, Inc. JJY Class I 1993-07-28
K926112 ACCUTEX BETA-HCG TEST J.S. Medical Assoc. JHJ Class II 1993-07-28
K932659 MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM More Diagnostics JJX Class I 1993-07-28
K926396 ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT Nichols Institute CKG Class II 1993-07-27
K931031 VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT Biomerieux Vitek, Inc. JFT Class II 1993-07-27
K931888 TOTAL BILIRUBIN Em Diagnostic Systems, Inc. CIG Class II 1993-07-27
K931889 CREATINE KINASE TEST Em Diagnostic Systems, Inc. CGS Class II 1993-07-27
K931601 CHEMILUMINESCENCE DHEA-S IMMUNOASSAY Nichols Institute JKC Class I 1993-07-27
K932044 DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD Dupont Medical Products CEM Class II 1993-07-27
K930732 DELFIA CORTISOL KIT Wallac OY JFT Class II 1993-07-27
K923503 URIC ACID ENZYMATIC COLORIMERIC KIT Randox Laboratories, Ltd. KNK Class I 1993-07-22
K931890 GLUCOSE-HK TEST Em Diagnostic Systems, Inc. CFR Class II 1993-07-22
K931294 IQ TUPTAKE ASSAY Becton Dickinson Advanced Diagnostics KHQ Class II 1993-07-22
K931295 IQ TT4 ASSAY Becton Dickinson Advanced Diagnostics CDX Class II 1993-07-20
K930475 LIQUID AMYLASE REAGENT SET Pointe Scientific, Inc., JFJ Class II 1993-07-19
K925970 MODEL 3D3 OSMOMETER Advanced Instruments, Inc. JJM Class I 1993-07-09
K932160 SYSTEMATE CREATININE TEST ITEM NUMBER 65413 Em Diagnostic Systems, Inc. CGX Class II 1993-07-09
K932279 OPUS(R) TOTAL B-HCG TEST SYSTEM Pb Diagnostic Systems, Inc. JHI Class II 1993-07-08
K930889 ROCHE CARDIOTROL-CK Roche Diagnostic Systems, Inc. JJT Class I 1993-07-06
K932409 SAS(TM) SERUM/URINE HCG Sa Scientific, Inc. DHA Class II 1993-06-29
K932113 CANNABINOID URINE CONTROLS Diagnostic Reagents, Inc. JJX Class I 1993-06-29
K932076 LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II Bio-Rad JJY Class I 1993-06-29
K932458 DOCUMENT ENZYME Casco Standards JJY Class I 1993-06-29
K930679 DIRECT BILIRUBIN Horizon Diagnostics, Inc. CIG Class II 1993-06-29
K932042 QUICKVUE ONE-STEP HCG COMBO Quidel Corp. JHI Class II 1993-06-29
K923663 MULTITROL IMMUNOLOGY CONTROL Behring Diagnostics, Inc. JJY Class I 1993-06-28
K922646 REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM Behring Diagnostics, Inc. JIS Class II 1993-06-25
K931310 GLUCOMETER M+ BLOOD GLUCOSE METER Heraeus Kulzer, Inc. CGA Class II 1993-06-25
K931523 QUANTIMETRIX C-CLEAR(TM) Quantimetrix Corp. JMA Class I 1993-06-25
K926361 GLUCOMETER ENCORE QA BLOOD GLUCOSE METER Heraeus Kulzer, Inc. CFR Class II 1993-06-24
K931761 QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) Quidel Corp. JJX Class I 1993-06-22
K931061 RADIAS TSH ENZYME IMMUNOASSAY Bio-Rad JLW Class II 1993-06-16
K931970 ABBOTT IMX2 ANALYER Abbott Laboratories JJI Class I 1993-06-16
K930008 COAT-A-COUNT INTACT PTH IRMA Diagnostic Products Corp. CEW Class II 1993-06-15
K925303 PRO-STEP PT HCG Disease Detection International, Inc. JHI Class II 1993-06-15
K931172 IMX(R) STAT CK-MB Abbott Laboratories JHY Class II 1993-06-15
K922207 TES-TAPE Lilly Research Laboratories CGA Class II 1993-06-15
K926475 ACCESS(R) THYROXINE ASSAY Bio-Rad Laboratories, Inc. KLI Class II 1993-06-15
K931326 KING DIAGNOSTICS CK REAGENT King Diagnostics, Inc. CGS Class II 1993-06-15
K931602 CHEMSTRIP URINE ANALYZER Boehringer Mannheim Corp. KQO Class I 1993-06-15
K931373 ANALYZER: STAT PROFILE PLUS 10 ANALYZER Nova Biomedical Corp. JJY Class I 1993-06-15
K931302 SAS PREGNANCY STRIP Sa Scientific, Inc. JHI Class II 1993-06-09
K931148 MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM Esa, Inc. CHQ Class I 1993-06-09
K926500 UC QIK PREGNANCY TEST Eucardio Laboratory, Inc. JHI Class II 1993-06-07
K930477 ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR Analytical Control Systems, Inc. JIS Class II 1993-06-07
K930010 ACCESS THYROID UPTAKE ASSAY Bio-Rad Laboratories, Inc. CEE Class II 1993-06-07
K926131 OPUS MAGNUM ANALYZER Pb Diagnostic Systems, Inc. KHO Class I 1993-06-07
K931188 CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC Cascade Medical, Inc. CGA Class II 1993-05-26

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.