meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
49
Latest Decision
2001-11-16

Clearances · page 32 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K013203 BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS Polymer Technology Systems, Inc. NBW Class II 2001-11-16
K013119 VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 Maine Standards Co. JJX Class I 2001-11-16
K013101 WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA Wiener Laboratories Saic JFJ Class II 2001-11-16
K013095 WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 Wiener Laboratories Saic CEO Class I 2001-11-16
K013097 WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 Wiener Laboratories Saic JIY Class I 2001-11-13
K013102 WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 Wiener Laboratories Saic JMO Class I 2001-11-13
K013152 ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS Elan Holdings, Inc. LBS Class I 2001-11-09
K013126 N LP(A) STANDARD SY Dade Behring, Inc. JIS Class II 2001-11-09
K013372 CLEARBLUE EASY EARLY RESULT PREGNANCY TEST Unipath , Ltd. LCX Class II 2001-11-09
K012326 WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 Wiener Laboratories Saic JGJ Class I 2001-11-08
K012987 PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER Phoenix Diagnostics, Inc. JIX Class II 2001-11-07
K013373 OMNI C ANALYZER Roche Diagnostics Corp. CEM Class II 2001-11-02
K012829 STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS Biocare Corp. KQO Class I 2001-11-02
K013147 GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE Bionostics, Inc. JJX Class I 2001-10-24
K013173 BIOSCANNER PLUS; LIPID PANEL TEST STRIPS Polymer Technology Systems, Inc. CHH Class I 2001-10-22
K013130 N LP(A) CONTROL SY Dade Behring, Inc. JJX Class I 2001-10-18
K013235 MODIFICATION TO SYNCHRON CONTROL Beckman Coulter, Inc. JJY Class I 2001-10-16
K012559 POLY STAT HCG TEST Bion Diagnostic Sciences JHI Class II 2001-10-16
K012878 THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 Thermo Dma, Inc. JIS Class II 2001-10-16
K012900 ACCESS UNCONJUGATED ESTRIOL CALIBRATORS Beckman Coulter, Inc. JIT Class II 2001-10-16
K013118 MODIFICATION TO ALPHA DX SYSTEM First Medical, Inc. JHX Class II 2001-10-15
K012668 RAICHEM GLUCOSE UV REAGENT Hemagen Diagnostics, Inc. CFR Class II 2001-10-15
K012649 RAICHEM BUN RATE REAGENT Hemagen Diagnostics, Inc. CDQ Class II 2001-10-15
K013194 UNIMARK HCG COMBO PREGNANCY TEST Biotech Atlantic, Inc. JHI Class II 2001-10-10
K012065 WIENER LAB. CREATININA CINETICA AA Wiener Laboratories Saic JFY Class II 2001-10-10
K012509 PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM Phoenix Diagnostics, Inc. JIX Class II 2001-10-09
K012230 PHEM-ALERT Femtek,Llc. LNW Class I 2001-10-09
K012367 VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D Nichols Institute Diagnostics JIT Class II 2001-10-09
K012518 TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 Thermo Dma, Inc. CJE Class II 2001-10-09
K012474 ATAC PAK CPK REAGENT KIT Elan Holdings, Inc. CGS Class II 2001-10-03
K012340 BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) Bayer Corp. JMO Class I 2001-10-01
K012470 MODIFICATION TO N PROTEIN STANDARD SL Dade Behring, Inc. JIX Class II 2001-09-28
K011568 RANDOX LIPOPROTEIN Randox Laboratories, Ltd. JIS Class II 2001-09-28
K011970 BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM Biosafe Laboratories, Inc. CHH Class I 2001-09-26
K012397 URISYS 2400 URINE TEST STRIP Roche Diagnostics Corp. JIL Class II 2001-09-26
K012250 RAICHEM MULTI-ANALYTE CALIBRATOR Hemagen Diagnostics, Inc. JIX Class II 2001-09-24
K012043 VACUETTE EDTA K2 GEL TUBES Greiner Vacuette North America, Inc. PJE Class II 2001-09-24
K012329 WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 Wiener Laboratories Saic CIX Class II 2001-09-21
K010844 ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K Astoria-Pacific, Inc. NAK Class II 2001-09-21
K012260 WIENER LAB. UREA UV CINETICA AA Wiener Laboratories Saic CDQ Class II 2001-09-19
K012152 DS30 HCY BLOOD COLLECTION TUBES Drew Scientific , Ltd. GIM Class II 2001-09-18
K011240 EVENCARE BLOOD GLUCOSE MONITORING SYSTEM Medline Industries, Inc. NBW Class II 2001-09-13
K001687 COLORMATE TLC BILITEST SYSTEM Chromatics Color Sciences Intl., Inc. MQM Class I 2001-09-13
K012205 GLUCOMETER DEX TEST SENSOR Bayer Corp. NBW Class II 2001-09-12
K012233 STRATUS CS TROPONIN I CALIBRATOR Dade Behring, Inc. JIT Class II 2001-09-11
K010973 DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 Hypoguard USA, Inc. JIL Class II 2001-09-11
K012332 JAS CARBON DIOXIDE LIQUID REAGENT Jas Diagnostics, Inc. KHS Class II 2001-09-06
K011128 NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) Nichols Institute Diagnostics CIB Class II 2001-09-06
K012656 LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 Bio-Rad JJT Class I 2001-09-06
K012468 MODIFICATION TO N/T PROTEIN CONTROL SL Dade Behring, Inc. JJY Class I 2001-09-04
K012855 LIQUISPX LIQUID LIPID CONTROL Clinical Controls Division JJY Class I 2001-08-30
K012593 VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc. LBR Class I 2001-08-30
K012561 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS Ortho-Clinical Diagnostics JJX Class I 2001-08-29
K012513 LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 Bio-Rad JJY Class I 2001-08-29
K012431 COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 Bionostics, Inc. JJY Class I 2001-08-28
K012284 WH ACCU TEST PREGNANCY TEST W.H.P.M., Inc. JHI Class II 2001-08-28
K011972 DIRECT BILIRUBIN REAGENT Intersect Systems, Inc. CIG Class II 2001-08-27
K012430 MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 Bionostics, Inc. JJX Class I 2001-08-27
K012399 MODIFICATION TO ELECSYS FSH II CALSET Roche Diagnostics Corp. JIT Class II 2001-08-24
K012252 QUIK-CHECK OVULATION PREDICTOR ACON Laboratories, Inc. CEP Class I 2001-08-24
K012038 JAS URIC ACID LIQUID REAGENT Jas Diagnostics, Inc. KNK Class I 2001-08-21
K012058 STAT PROFILE PHOX PLUS L ANALYZER Nova Biomedical Corp. CHL Class II 2001-08-20
K012122 VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 Maine Standards Co. JJX Class I 2001-08-20
K012120 VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 Maine Standards Co. JJY Class I 2001-08-20
K012117 VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 Maine Standards Co. JJY Class I 2001-08-20
K012243 MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL Hematronix, Inc. JJY Class I 2001-08-20
K012118 VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 Maine Standards Co. JJY Class I 2001-08-20
K012478 MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER I-Stat Corp. CHL Class II 2001-08-20
K012119 VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 Maine Standards Co. JJY Class I 2001-08-20
K011551 SURE CHECK PREGNANCY TEST Chembio Diagnostic Systems, Inc. LCX Class II 2001-08-14
K011550 HCG STAT PAK ULTRA-FAST Chembio Diagnostic Systems, Inc. JHI Class II 2001-08-14
K011843 GENZYME DIRECT-AMYLASE TEST REAGENT Genzyme Corp. JFJ Class II 2001-08-10
K010039 QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION Chronimed, Inc. NBW Class II 2001-08-10
K012210 MODIFICATION TO ACCU-CHEK INFORM METER Roche Diagnostics Corp. NBW Class II 2001-08-09
K012286 MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION Roche Diagnostics Corp. LBS Class I 2001-08-08
K012287 MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION Roche Diagnostics Corp. MRR Class I 2001-08-07
K012215 QUIK-CHECK HOME PREGNANCY TEST ACON Laboratories, Inc. LCX Class II 2001-08-07
K011527 PRAXSYS RELIA TSH TEST Praxsys Biosystems, Inc. JLW Class II 2001-08-07
K010332 WAKO IMMUNOASSAY CALIBRATOR SET Wako Chemicals USA, Inc. JIT Class II 2001-08-01
K010500 AUTOMATED WORKCELL CONTROL SOFTWARE Lab-Interlink, Inc. JJE Class I 2001-08-01
K010522 SUREVUE URINE HCG Sa Scientific, Inc. JHI Class II 2001-07-31
K011658 CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS Rochdiag JIX Class II 2001-07-31
K011900 GLUCOSE (HEXOKINASE) Jas Diagnostics, Inc. CFR Class II 2001-07-31
K011052 OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE Ostex Intl., Inc. JMM Class I 2001-07-30
K011692 HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT Intersect Systems, Inc. LPS Class II 2001-07-25
K011689 HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT Catch, Inc. LPS Class II 2001-07-25
K010337 LIPOPRINT SYSTEM, LDL SUBFRACTIONS Quantimetrix Corp. JHO Class I 2001-07-25
K011599 ALKALINE PHOSPHATASE LIQUID REAGENT Jas Diagnostics, Inc. CJE Class II 2001-07-20
K011853 ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 Bio-Rad JJY Class I 2001-07-17
K011596 UREA NITROGEN (BUN) LIQUID REAGENT Jas Diagnostic, Inc. CDQ Class II 2001-07-17
K011525 SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) Biosafe Laboratories, Inc. JLW Class II 2001-07-16
K011867 LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 Bio-Rad JJY Class I 2001-07-12
K010871 TGL FLEX REAGENT CARTRIDGE Dade Behring, Inc. CDT Class I 2001-07-09
K011441 JAS CALCIUM (ARSENAZO) REAGENT Jas Diagnostics, Inc. CJY Class II 2001-07-09
K011731 TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 Medical Analysis Systems, Inc. JJY Class I 2001-07-05
K011478 I-STAT SYSTEM I-Stat Corp. KHP Class I 2001-07-02
K011505 IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 Diagnostic Products Corp. CEW Class II 2001-07-02
K011699 VACUETTE EVACUATED BLOOD COLLECTION TUBES Greiner Bio-One Vacuette North America JKA Class II 2001-06-28
K011579 LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 Bio-Rad JJY Class I 2001-06-26
K011145 MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 Roche Diagnostics Corp. JFJ Class II 2001-06-25

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