meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
54
Latest Decision
1999-11-12

Clearances · page 36 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K991315 MICROALBUSTIX REAGENT STRIPS (OTC) Bayer Corp. JIR Class I 1999-11-12
K993254 IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 Diagnostic Products Corp. CGN Class II 1999-11-12
K992770 QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 Seracare Technology JJY Class I 1999-11-12
K993219 WAKO BILIRUBIN CALIBRATOR Wako Chemicals USA, Inc. JIS Class II 1999-11-09
K992136 BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) Bayer Corp. CIT Class II 1999-11-09
K993469 WAKO L-TYPE UA F TEST Wako Chemicals USA, Inc. KNK Class I 1999-11-09
K992741 LYPHOCHEK ANEMIA CONTROL, MODEL 500 Bio-Rad JJY Class I 1999-11-09
K992997 OSTEOMARK NTX POC Metrika, Inc. JMM Class I 1999-11-09
K993466 WAKO L-TYPE TRIGLYCERIDE TEST Wako Chemicals USA, Inc. CDT Class I 1999-11-09
K993141 AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 Phamatech LCX Class II 1999-11-08
K993536 BIO-RAD CODA NEONATAL GALT ASSAY Bio-Rad KQP Class II 1999-11-04
K984433 QUANTECH CK-MB ASSAY Quantech , Ltd. MYT Class II 1999-11-01
K992858 ABBOTT AXSYM HOMOCYSTEINE Abbott Laboratories LPS Class II 1999-10-25
K993211 PICCOLO SODIUM TEST SYSTEM Abaxis, Inc. JGS Class II 1999-10-25
K992695 INSURE PRO TEST Inbios Intl., Inc. JHI Class II 1999-10-18
K992971 REP CHOLESTEROL PROFILE KIT Helena Laboratories JHO Class I 1999-10-18
K993178 UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 Diagnostic Chemicals , Ltd. CDQ Class II 1999-10-18
K992766 N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET Genzyme Corp. MRR Class I 1999-10-18
K992846 HICHEM TOTAL PROTEIN REAGENT Elan Holdings, Inc. CEK Class II 1999-10-18
K992845 HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT Elan Holdings, Inc. JIX Class II 1999-10-18
K992847 HICHEM BUN REAGENT Elan Holdings, Inc. LFP Class II 1999-10-14
K992366 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK Ortho-Clinical Diagnostics, Inc. MMI Class II 1999-10-08
K993065 ACON COMBO PREGNANCY ACON Laboratories, Inc. JHI Class II 1999-10-08
K993098 HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 Data Medical Associates, Inc. JIX Class II 1999-10-08
K992274 MODIFICATION TO IMX HOMOCYSTEINE Axis Biochemicals, Asa LPS Class II 1999-10-06
K993083 ALCYON 300I (WITH ISE MODULE) ANALYZER Abbott Laboratories CEM Class II 1999-10-05
K992127 CARDIOQUANT TROPONIN I TEST Spectral Diagnostics, Inc. MMI Class II 1999-10-04
K993068 VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS Ortho-Clinical Diagnostics JHX Class II 1999-10-04
K993132 GENZYME DIRECT AMYLASE VERIFIER Genzyme Corp. JIT Class II 1999-10-04
K992680 ELECSYS PARATHYROID HORMONE TEST SYSTEM Roche Diagnostics Corp. CEW Class II 1999-09-28
K992800 SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P Sigma Diagnostics, Inc. CDQ Class II 1999-09-28
K992801 SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 Sigma Diagnostics, Inc. CIT Class II 1999-09-28
K992798 SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P Sigma Diagnostics, Inc. CDO Class I 1999-09-28
K991800 HEMOCHEK URINE COLLECTION KIT Osborn Group, Inc. JIQ Class I 1999-09-24
K992988 PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM Home Diagnostics, Inc. CGA Class II 1999-09-24
K992981 ELECSYS ESTRADIOL CALSET II Roche Diagnostics Corp. JIT Class II 1999-09-24
K991551 VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1999-09-23
K991927 MEDI-TEST COMBI 11 Macherey-Nagel-Duren JIL Class II 1999-09-17
K991998 GAMMA-B 25-HYDROXY VITAMIN D RIA Immunodiagnostic Systems , Ltd. MRG Class II 1999-09-17
K991480 EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP Selfcare, Inc. CGA Class II 1999-09-17
K991532 DRX QT. HCG Metrika, Inc. DHA Class II 1999-09-17
K992399 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM Bayer Corp. CIX Class II 1999-09-15
K992475 CARESIDE CO2, TOTAL Careside, Inc. KHS Class II 1999-09-15
K992803 SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP Sigma Diagnostics, Inc. CHH Class I 1999-09-13
K991834 CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 Cholestech Corp. CKD Class I 1999-09-09
K991754 GO GLUCOSE MONITORING SYSTEM Lxn Corp. CGA Class II 1999-09-08
K992576 URINE CHEMISTRY CONTROL, LEVEL 1 Consolidated Technologies, Inc. JJW Class I 1999-09-03
K992578 URINE CHEMISTRY CONTROL, LEVEL 2 Consolidated Technologies, Inc. JJW Class I 1999-09-03
K992172 LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 Bio-Rad JJY Class I 1999-09-02
K991762 ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 A.P. Total Care, Inc. CJE Class II 1999-09-02
K991761 MAGNESIUM PRODUCT NO'S, 112-01, 112-02 A.P. Total Care, Inc. JGJ Class I 1999-09-02
K990873 DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE Ameritek, Inc. JMT Class I 1999-09-01
K992430 CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 Medical Analysis Systems, Inc. JJT Class I 1999-08-30
K992140 PICCOLO METLYTE 7 REAGENT DISC Abaxis, Inc. JLB Class I 1999-08-26
K992397 ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE Cenogenics Corp. JHI Class II 1999-08-26
K992349 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. JJY Class I 1999-08-24
K992132 CHOLESITE TEST SYSTEM Gds Technology, LLC CHH Class I 1999-08-20
K991083 RLP CHOLESTEROL IMMUNOSEPARATION ASSAY Otsuka Pharmaceutical Co., Ltd. CHH Class I 1999-08-20
K991664 LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 A.P. Total Care, Inc. LBS Class I 1999-08-19
K992086 OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 Olympus America, Inc. JIX Class II 1999-08-19
K992029 ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS Elan Diagnostics LBR Class I 1999-08-12
K992550 LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 Bio-Rad JJY Class I 1999-08-11
K991717 CARESIDE MG Careside, Inc. JGJ Class I 1999-08-10
K991665 HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 A.P. Total Care, Inc. LBS Class I 1999-08-10
K992365 AIA-PACK FOLATE ASSAY Tosoh Medics, Inc. CGN Class II 1999-08-10
K984530 DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE Metrika, Inc. JFY Class II 1999-08-10
K992002 AUTOHDL CHOLESTEROL REAGENT SET Pointe Scientific, Inc., LBR Class I 1999-08-05
K991371 CARESIDE AMMONIA Careside, Inc. JID Class I 1999-08-03
K991867 INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 A.P. Total Care, Inc. CEO Class I 1999-08-02
K990942 DUET II GLUCOSE CONTROL MONITORING SYSTEM Lxn Corp. CGA Class II 1999-08-02
K991866 BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 A.P. Total Care, Inc. CIG Class II 1999-08-02
K991870 ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 A.P. Total Care, Inc. CGZ Class II 1999-07-30
K991702 MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 Becton Dickinson Vacutainer Systems JKA Class II 1999-07-28
K992244 GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE Greiner Meditech, Inc. JKA Class II 1999-07-26
K992034 DOCUMENT THYROID CAL*VER Casco-Nerl Diagnostics Corporation (Maine) JJY Class I 1999-07-23
K991741 BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 Biocheck, Inc. JHI Class II 1999-07-22
K991817 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM Bayer Corp. CIJ Class II 1999-07-22
K991727 STAT PROFILE M7 ANALYZER Nova Biomedical Corp. CGL Class II 1999-07-16
K991705 N PROTEIN STANDARD UY Dade Behring, Inc. JIT Class II 1999-07-15
K992163 ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS Pdz-Europa , Ltd. DOP Class I 1999-07-13
K991733 ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS Schiapparelli Biosystems, Inc. MRR Class I 1999-07-13
K991917 OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET Metrika, Inc. JJW Class I 1999-07-12
K991789 ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS Elan Holdings, Inc. LBR Class I 1999-07-09
K990649 GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS Bayer Corp. CGA Class II 1999-07-09
K983504 PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST Medisense, Inc. CGA Class II 1999-07-09
K990843 SERUM CROSSLAPS ONE STEP ELISA Osteometer Biotech A/S JMM Class I 1999-07-09
K992105 IMMULITE TURBO INTACT PTH, MODEL LSKPTZ Diagnostic Products Corp. CEW Class II 1999-07-06
K991177 OPUS TROPONIN I (CTN) TEST MODULES Dade Behring, Inc. MMI Class II 1999-07-01
K991176 OPUS TROPONIN I CALIBRATOR Dade Behring, Inc. JIT Class II 1999-07-01
K991242 GLUCOMETER ELITE TEST STRIPS Bayer Corp. CGA Class II 1999-06-30
K991663 AST/SGOT A.P. Total Care, Inc. CIT Class II 1999-06-30
K991576 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp. CIX Class II 1999-06-30
K991582 CHIRON DIAGNOSTICS ACS: 180 FOLATE Chiron Diagnostics Corp. CGN Class II 1999-06-30
K991666 TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 A.P. Total Care, Inc. JMO Class I 1999-06-30
K991843 GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE Greiner Meditech, Inc. JKA Class II 1999-06-25
K991704 N/T PROTEIN CONTROL LC Dade Behring, Inc. JJY Class I 1999-06-25
K990688 MTM BIOSCANNER C TEST STRIPS Polymer Technology Systems, Inc. CHH Class I 1999-06-24
K983344 DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL Dade Behring, Inc. CGA Class II 1999-06-22
K991146 TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 Biocheck, Inc. JLW Class II 1999-06-22
K990993 BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 Biocheck, Inc. JLW Class II 1999-06-22

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