meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
49
Latest Decision
1993-01-26

Clearances · page 59 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K925110 ABBOTT IMX T4 Abbott Laboratories CDX Class II 1993-01-26
K925337 OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT Olympus Corp. JQB Class I 1993-01-26
K921412 MICROPROTEIN REAGENT SET Sterling Diagnostics, Inc. CEK Class II 1993-01-21
K925377 IMX PAP Abbott Laboratories JFH Class II 1993-01-13
K924904 HDL-CHOLESTEROL STANDARD, MODIFICATION Verichem Laboratories, Inc. JIS Class II 1993-01-13
K925125 PRO-STEP HCG Disease Detection International, Inc. JHI Class II 1993-01-13
K924856 AIA-PACK PRL CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. JJX Class I 1993-01-11
K924852 ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. JJX Class I 1993-01-11
K924493 DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD Casco Standards JJX Class I 1993-01-11
K924674 DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT Genzyme Corp. MRR Class I 1993-01-06
K925189 PREGNAGEN 1-STEP PREGNANCY TEST Biogenex Laboratories LCX Class II 1993-01-06
K925998 ACTIVE RENIN IMMUNORADIOMETRIC ASSAY Nichols Institute Diagnostics CIB Class II 1993-01-06
K926046 DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III Baxter Diagnostics, Inc. JJY Class I 1993-01-05
K925002 UREA NITROGEN TEST Em Diagnostic Systems, Inc. CDQ Class II 1993-01-04
K925109 ABBOTT TDX/TDXFLX TT4 Abbott Laboratories CDX Class II 1993-01-04
K924832 OLYMPUS CREATINE KINASE REAGENT Olympus Corp. CGS Class II 1993-01-04
K924244 ROCHE REAGENT FOR AST Roche Diagnostic Systems, Inc. CIT Class II 1993-01-04
K924659 OLYUMPUS TOTAL PROTEIN REAGENT Olympus Corp. CEK Class II 1992-12-29
K924020 ELECTROPHORESIS TANK The Binding Site, Ltd. JJN Class I 1992-12-28
K924365 VACUPLUS TUBES WITH BRICK RED STOPPERS Starplex Scientific, Inc. JKA Class II 1992-12-28
K925257 CIBA CORNING ACS T UPTAKE IMMUNOASSAY Ciba Corning Diagnostics Corp. KHQ Class II 1992-12-28
K925132 BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE Becton Dickinson Advanced Diagnostics JLW Class II 1992-12-28
K924862 AIA-PACK HCG CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. JJX Class I 1992-12-28
K924853 AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. JJX Class I 1992-12-28
K925801 REP E-Z CK-30 ISOENZYME KIT Helena Laboratories CGS Class II 1992-12-28
K925096 CONCEIVE ONE-STEP PREGNANCY TEST Quidel Corp. LCX Class II 1992-12-28
K925668 CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM E.I. Dupont DE Nemours & Co., Inc. CGX Class II 1992-12-28
K925436 MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. CDP Class II 1992-12-28
K923587 GLUCOSE TEST SYSTEM Polymer Technology Corp. CGA Class II 1992-12-28
K923959 ALBUMIN TEST Em Diagnostic Systems, Inc. CIX Class II 1992-12-28
K926015 CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 Cala Diagnostics JJX Class I 1992-12-28
K923925 HCG STAT-PAK Chembio Diagnostic Systems, Inc. JHI Class II 1992-12-24
K925702 NICHOLS APO B CHEMILUMINESCENCE ASSAY Nichols Institute Diagnostics MSJ Class I 1992-12-23
K924398 UNI-CHECK REAGENT STRIP Diagnostic Solutions, Inc. CGA Class II 1992-12-23
K924915 SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 Helena Laboratories JJY Class I 1992-12-18
K924691 OLYMPUS IRON REAGENT Olympus Corp. JIY Class I 1992-12-18
K924499 ELITE TEST STRIPS GLUCOMETER Heraeus Kulzer, Inc. CGA Class II 1992-12-17
K925151 LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3 Bio-Rad JJT Class I 1992-12-17
K924347 WATERS(TM) 996 PDA Millipore Corp. KIE Class I 1992-12-11
K923844 LYRIS 100/120 LABORATORY INFORMATION SYSTEM Biovation, Inc. JJQ Class I 1992-12-11
K925338 OLYMPUS CHLORIDE REAGENT Olympus Corp. CHJ Class II 1992-12-11
K923879 ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE Diagnostic Products Corp. JQW Class I 1992-12-07
K924758 DMI BLOOD GAS ANALYZER/CARTRIDGE Diamond Medical, Inc. CHL Class II 1992-12-03
K924601 OLYMPUS GLUCOSE REAGENT Olympus Corp. CFR Class II 1992-12-03
K924711 BICARBONATE Em Diagnostic Systems, Inc. KHS Class II 1992-12-03
K923507 ALKALINE PHOSPHATASE KIT Randox Laboratories, Ltd. CJE Class II 1992-12-03
K923410 FIAGEN PROGESTERONE Cyberfluor, Inc. JLS Class I 1992-12-03
K924964 OLYMPUS TOTAL BILIRUBIN REAGENT Olympus Corp. CIG Class II 1992-12-03
K925435 QUICKVUE ONE-STEP HCG TEST Quidel Corp. JHI Class II 1992-12-03
K923509 GAMMA-GT Randox Laboratories, Ltd. JPZ Class I 1992-12-03
K923544 ONE TOUCH TEST STRIPS Lifescan, Inc. CGA Class II 1992-12-03
K924428 SYNERMED ENZYMATIC CO2 REAGENT KIT Synermed, Inc. KHS Class II 1992-12-03
K924963 OLYMPUS DIRECT BILIRUBIN REAGENT Olympus Corp. CIG Class II 1992-11-30
K925177 VIDAS FREE THYROXINE(FT4) ASSAY Biomerieux Vitek, Inc. CEC Class II 1992-11-30
K924257 TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. CDZ Class I 1992-11-30
K923401 DELFIA HTSH ULTRA KIT Wallac OY JLW Class II 1992-11-30
K924259 MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 Medix Biotech, Inc. JHI Class II 1992-11-25
K925203 TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 Heraeus Kulzer, Inc. JJQ Class I 1992-11-25
K924572 EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 Em Diagnostic Systems, Inc. CFR Class II 1992-11-25
K924693 OLYMPUS BUN REAGENT Olympus Corp. CDQ Class II 1992-11-25
K922467 SYNCHRON TOTAL PROTEIN TEST --MODIFIED Beckman Instruments, Inc. CEK Class II 1992-11-23
K925057 OLYMPUS INORGANIC PHOSPHORUS REAGENT Olympus Corp. CEO Class I 1992-11-19
K924246 ROCHE REAGENT FOR GGT Roche Diagnostic Systems, Inc. JQB Class I 1992-11-18
K922231 OLYMPUS CHOLESTEROL REAGENT Olympus Corp. CHH Class I 1992-11-18
K925156 OLYMPUS ALKALINE PHOSPHATASE REAGENT Olympus Corp. CJE Class II 1992-11-18
K924675 TSH - THIRD GENERATION LOW CONTROLS Nichols Institute JJX Class I 1992-11-18
K923158 LUMICO ANALYZER SA-300 Maruzen Petrochemical Co., Ltd. JJQ Class I 1992-11-17
K923510 ALT (GPT) - ALANINE AMINOTRANSFERASE Randox Laboratories, Ltd. CKA Class I 1992-11-16
K924854 AIA-PACK PAP CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. JJX Class I 1992-11-16
K922329 BERTHOLD LB 954 Eg&G Berthold Analytical Instruments, Inc. JJQ Class I 1992-11-16
K922976 LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT Eg&G Berthold Analytical Instruments, Inc. JJQ Class I 1992-11-16
K922858 MULTIDRAW SYSTEM Cambridge Multi-Draw, Inc. GIM Class II 1992-11-16
K924863 AIA-PACK FSH CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. JJX Class I 1992-11-16
K923505 AST (GOT) - ASPARTATE AMINOTRANSFERASE Randox Laboratories, Ltd. CIT Class II 1992-11-16
K924855 AIA-PACK T-U CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. JJX Class I 1992-11-16
K924965 OLYMPUS LACTATE DEHYDROGENASE REAGENT Olympus Corp. CFJ Class II 1992-11-16
K923572 VISTA FREE THYROXINE ASSAY Syva Co. CEC Class II 1992-11-16
K922631 STATPAL II BLOOD GAS ANALYSIS SYSTEM Ppg Industries, Inc. CHL Class II 1992-11-10
K924427 SYNERMED HDL CHOLESTLEROL REAGENT KIT Synermed, Inc. LBR Class I 1992-11-09
K924574 EMDS ALKALINE PHOSPHATASE (ALP) TEST Em Diagnostic Systems, Inc. CJE Class II 1992-11-09
K924743 NOVA 12 ANALYZER, MODIFICATION Nova Biomedical Corp. CGA Class II 1992-11-06
K924471 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL) Eastman Kodak Company JGS Class II 1992-11-06
K924864 NOVA 13 ANALYZER, MODIFICATION Nova Biomedical Corp. CGZ Class II 1992-11-06
K924573 SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST Em Diagnostic Systems, Inc. CDT Class I 1992-11-06
K923793 DOCUMENT CHEM III CALIBRATION VERIFICATION TEST Casco Standards JJX Class I 1992-11-05
K922803 WELLWASH 4 MARK II Denley Instruments, Inc. JQW Class I 1992-11-05
K923794 DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET Casco Standards JJX Class I 1992-11-05
K923795 DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET Casco Standards JJY Class I 1992-11-05
K923821 DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET Casco Standards JJX Class I 1992-11-05
K921477 I-STAT(TM) LEVELS 1,2,3 CONTROLS I-Stat Corp. JJY Class I 1992-11-02
K923129 KING DIAGNOSTICS GLUCOSE (HK) REAGENT King Diagnostics, Inc. CFR Class II 1992-11-02
K924694 LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC Olympus Corp. CDT Class I 1992-10-28
K923087 IL TEST APOLIPOPROTEIN A1 Instrumentation Laboratory CO MSJ Class I 1992-10-26
K924074 STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED Baxter Diagnostics, Inc. CDD Class II 1992-10-26
K923733 CHOLESTEROL TEST Em Diagnostic Systems, Inc. CHH Class I 1992-10-26
K922713 KODAK AMERLITE MAB FT3 ASSAY Eastman Kodak Company CEC Class II 1992-10-26
K923080 IL TEST APOLIPOROTEIN B (APO B) Instrumentation Laboratory CO MSJ Class I 1992-10-26
K923641 IL TEST AST, PN 35312 Instrumentation Laboratory CO CIT Class II 1992-10-26
K924245 ROCHE REAGENT FOR ALT Roche Diagnostic Systems, Inc. CKA Class I 1992-10-22
K924435 OLYMPUS CALCIUM REAGENT Olympus Corp. CIC Class II 1992-10-19

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