meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
57
Latest Decision
1996-01-05

Clearances · page 49 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K954839 ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV Sigma Diagnostics, Inc. CIT Class II 1996-01-05
K952320 PYRILINKS-D ASSAY KIT Metra Biosystems, Inc. JMM Class I 1995-12-29
K955390 INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY Corning Nichols Diagnostics CFL Class I 1995-12-29
K954546 BLOOD GAS MIXTURE Liquid Technology Corp. JIS Class II 1995-12-28
K955340 EUROTROL GAS - ISE CONTROL Direct Solutions JJS Class I 1995-12-26
K951223 CK-MB (NAC-ACT) Randox Laboratories, Ltd. CGS Class II 1995-12-26
K954807 CEDIA T UPTAKE ASSAY Boehringer Mannheim Corp. KHQ Class II 1995-12-21
K955440 IMMULITE SHBG (MODIFICATION) Diagnostic Products Corp. CDZ Class I 1995-12-21
K954655 ROCHE CONTROL SERUM N Roche Diagnostic Systems, Inc. JJY Class I 1995-12-21
K954656 ROCHE CONTROL SERUM P Roche Diagnostic Systems, Inc. JJY Class I 1995-12-21
K953486 MIT ONE STEP PREGNANCY TEST 3c Diagnostics, Inc. JHI Class II 1995-12-21
K955097 AMERLITE MAB FT4 ASSAY Kodak Clinical Diagnostics, Ltd. CEC Class II 1995-12-20
K955300 TOTAL BILIRUBIN PROCEDURE Data Medical Associates, Inc. CIG Class II 1995-12-20
K954591 AIA-PACK CORT ASSAY Tosoh Medics, Inc. JFT Class II 1995-12-15
K954993 QUIX RAPID PREGNANCY STRIP TEST Guardian Scientific, Corp. JHI Class II 1995-12-13
K954697 CIBA CORNING ACS ESTRADIOL-6 ASSAY Ciba Corning Diagnostics Corp. CHP Class I 1995-12-13
K951494 AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) Emd Chemicals, Inc. CIJ Class II 1995-12-11
K955154 CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT Alko Diagnostic Corp. JIX Class II 1995-12-11
K954901 BIONIKE A/Q PREGNANCY TEST Bionike Laboratories, Inc. JHI Class II 1995-12-11
K954179 HDL PRECIPITATING REAGENT Schiapparelli Biosystems, Inc. LBR Class I 1995-12-11
K955141 OSOM HCG COMBO TEST Wyntek Diagnostics, Inc. JJX Class I 1995-12-06
K954733 ACCESS CORTISOL ASSAY (MODIFICATION) Bio-Rad Laboratories, Inc. CGR Class II 1995-12-05
K955077 ANTHOS 2010 READER Anthos Labtec, Inc. JJQ Class I 1995-12-04
K954482 SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM Cirrus Medical,Inc. CHL Class II 1995-12-04
K954711 STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION) Nova Biomedical Corp. CHL Class II 1995-11-30
K954755 COAT-A-COUNT DIRECT ANDROSTENEDIONE Diagnostic Products Corp. CIZ Class I 1995-11-29
K954592 VACUTAINER BRAND PST PLASMA SEPARATION TUBE Becton Dickinson Vacutainer Systems JKA Class II 1995-11-28
K955024 LIQUICHEK ETHANOL/AMMONIA CONTROL Bio-Rad JJY Class I 1995-11-28
K952746 ALKALINE PHOSPHATASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. CJE Class II 1995-11-27
K954778 CHOLESTECH LDX SYSTEM Cholestech Corp. LBS Class I 1995-11-24
K952719 BIOCIRCUITS IOS (IN-OFFICE SYSTEM) Biocircuits Corp. KHO Class I 1995-11-22
K954825 ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Bio-Rad Laboratories, Inc. JLW Class II 1995-11-21
K953345 GENESIS Tecan U.S., Inc. JQW Class I 1995-11-21
K952875 ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS Boehringer Mannheim Corp. CGA Class II 1995-11-21
K953935 MED-TECH CLINICAL BLOOD GAS Medical Technical Gases Inc.. CHL Class II 1995-11-20
K952751 BIOCIRCUITS IOS T4/TU TEST CARTRIDGES Biocircuits Corp. KLI Class II 1995-11-20
K953837 BIOCIRCUITS IOS T4 TEST CARTRIDGE Biocircuits Corp. KLI Class II 1995-11-20
K945961 CALCITONIN IMMUNOASSAY KIT Nichols Institute Diagnostics JKR Class II 1995-11-20
K954732 ACCESS TOTAL BHCG ASSAY (MODIFICATION) Bio-Rad Laboratories, Inc. JHI Class II 1995-11-20
K951685 AURAFLEX TESTOSTERONE CALIBRATOR PACK Organon Teknika Corp. CDZ Class I 1995-11-14
K953883 ACCESS LOW LEVEL IGE CONTROLS Bio-Rad Laboratories, Inc. JJX Class I 1995-11-14
K952478 BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY Boehringer Mannheim Corp. MMI Class II 1995-11-09
K951329 IMMUCHEM GAL-MW EA Icn Pharmaceuticals, Inc. JIA Class I 1995-11-09
K954612 ABL SYSTEM 625, 615, 605 Radiometer America, Inc. CHL Class II 1995-11-09
K954323 MAS LIQUID URINALYSIS CONTROL Medical Analysis Systems, Inc. JJY Class I 1995-11-09
K946166 FIRST CHOICE(TM) TEST STRIP Polymer Technology Intl. CGA Class II 1995-11-08
K950628 FIRST CHOICE TEST STRIP Polymer Technology Intl. CGA Class II 1995-11-08
K954418 INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) Nichols Institute Diagnostics CEW Class II 1995-11-03
K952506 PYRILINKS ASSAY KIT Metra Biosystems, Inc. JMM Class I 1995-11-03
K945519 FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM Pharmaquest Corp. MPG Class I 1995-11-03
K952026 PYRILINKS POLYCLONAL ASSAY KIT Metra Biosystems, Inc. JMM Class I 1995-11-03
K954298 VIROTROL IV Blackhawk Biosystems, Inc. JJY Class I 1995-11-01
K954346 CHEMSTRIP MICRAL URINE TEST STRIPS Boehringer Mannheim Corp. JIR Class I 1995-10-26
K953710 ELX808 AUTOMATED MICROPLATE READERS Bio-Tek Instruments, Inc. JJQ Class I 1995-10-25
K954000 ROCHE REAGENT FOR BUN Roche Diagnostic Systems, Inc. CDQ Class II 1995-10-25
K954178 OSOM PREGNANCY TEST Wyntek Diagnostics, Inc. LCX Class II 1995-10-23
K954024 CHEMSTRIP CRITERION URINE ANALYZER Boehringer Mannheim Corp. KQO Class I 1995-10-23
K954187 TRIGLYCERIDES REAGENT Schiapparelli Biosystems, Inc. JGY Class I 1995-10-23
K952178 PH-DETECT TEST Diagnostic Reagents, Inc. JQY Class I 1995-10-20
K954680 ACCESS PROLACTIN ASSAY (MODIFICATION) Bio-Rad Laboratories, Inc. CFT Class I 1995-10-20
K954299 BUHLMANN ANGIOSTENSIN II RIA Buhlmann Laboratories AG CIB Class II 1995-10-19
K953572 ELX800UV Bio-Tek Instruments, Inc. JJQ Class I 1995-10-19
K952621 EML105 ELECTROLYTE METABOLITE ANALYZER Radiometer America, Inc. CGA Class II 1995-10-17
K951753 MEDTEC AUTOBLOT 2000 Medtec, Inc. JQW Class I 1995-10-17
K954273 CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG Quidel Corp. JHI Class II 1995-10-16
K952488 TRACE COBAS MIRA RANGE Trace Scientific , Ltd. CIX Class II 1995-10-13
K954364 CAMEO HOME PREGNANCY TEST Quidel Corp. LCX Class II 1995-10-13
K954266 STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY Solarcare Technologies Corp,Inc. CGX Class II 1995-10-13
K954312 ACTIVE THYROXINE RIA Diagnostic Systems Laboratories, Inc. CDX Class II 1995-10-07
K954074 AALTO SCIENTIFIC LIQUID CARDIAC CONTROL Aalto Scientific, Ltd. JJY Class I 1995-10-07
K954144 OPUS HCG CONTROLS Behring Diagnostics, Inc. JJX Class I 1995-10-06
K952410 CARBON DIOXIDE - DST Trace America, Inc. KHS Class II 1995-10-05
K950172 WAKO AUTOKIT GLUCOSE Wako Chemicals USA, Inc. CGA Class II 1995-10-05
K954029 TESTPACK PLUS HCG URINE Abbott Laboratories JHI Class II 1995-10-05
K953979 APOLIPOPROTEIN CALIBRATOR (APO-CAL) Beckman Instruments, Inc. JIX Class II 1995-10-03
K953656 ABBOTT IMX PROLACTIN(MODIFICATION) Abbott Mfg., Inc. CFT Class I 1995-10-03
K952437 DMA GLUCOSE HEXOKINASE U.V. PROCEDURE Data Medical Associates, Inc. CFR Class II 1995-10-03
K953581 FIRST RESPONSE OVULATION PREDICTOR TEST Armkel, LLC CEP Class I 1995-10-03
K951705 MINISTRIP HCG International Newtech Development, Inc. JHI Class II 1995-10-03
K953605 ULTRA-SENSITIVE ESTRADIOL Diagnostic Systems Laboratories, Inc. CHP Class I 1995-10-02
K952743 ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. CIT Class II 1995-09-29
K953005 BILI-METER Olympic Medical Corp. JJQ Class I 1995-09-28
K953994 SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM Becton Dickinson Vacutainer Systems JKA Class II 1995-09-26
K953657 ABBOTT AXSYM PROLACTIN(MODIFICATION) Abbott Mfg., Inc. CFT Class I 1995-09-25
K953239 BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER Boehringer Mannheim Corp. JJE Class I 1995-09-25
K953084 ACCESS ULTRASENSITIVE INSULIN ASSAY Bio-Rad Laboratories, Inc. CFP Class I 1995-09-25
K952385 HEMA-TROL Q-CHECK Medical Specialties Intl., Inc. JJY Class I 1995-09-25
K950803 ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE Isolab, Inc. JJT Class I 1995-09-21
K952427 CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE Beckman Instruments, Inc. CKA Class I 1995-09-21
K935712 IRON/TIBC REAGENT Horizon Diagnostics, Inc. JIY Class I 1995-09-20
K942706 ROCHE CALIBRATOR SERUM Roche Diagnostic Systems, Inc. JIX Class II 1995-09-20
K953463 VACUTAINER PLUS TUBES Becton Dickinson Vacutainer Systems JKA Class II 1995-09-20
K952282 ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR Roche Diagnostic Systems, Inc. JIX Class II 1995-09-15
K953652 PRENVAL I Base Ten Systems, Inc. JQP Class I 1995-09-15
K950382 APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT Randox Laboratories, Ltd. JHN Class I 1995-09-15
K950383 APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT Randox Laboratories, Ltd. JHN Class I 1995-09-15
K952615 WAKO AUTOKIT APO A1 Wako Chemicals USA, Inc. JHN Class I 1995-09-08
K952251 IMMULITE HCG HIGH LEVEL CONTROL MODULE Diagnostic Products Corp. JJX Class I 1995-09-08
K951595 ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES Roche Diagnostic Systems, Inc. CGX Class II 1995-09-08
K953862 HICHEM ISEKCI SOLUTION KIT 70010 Hichem Diagnostics CGZ Class II 1995-09-06

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