meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
48
Latest Decision
2001-06-25

Clearances · page 33 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K010334 WAKO LIPID CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 2001-06-25
K011226 CALIBRATOR FOR AUTOMATED SYSTEMS Roche Diagnostics Corp. JIX Class II 2001-06-25
K011720 OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. CIX Class II 2001-06-25
K011616 INDUO BLOOD GLUCOSE METER Inverness Medical Innovations, Inc. NBW Class II 2001-06-21
K010456 BIOSCANNER CREATININE TEST STRIPS Polymer Technology Systems, Inc. JFY Class II 2001-06-20
K011738 ACCU-CHEK ACTIVE SYSTEM Roche Diagnostics Corp. NBW Class II 2001-06-20
K010553 PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY Abbott Laboratories NBW Class II 2001-06-18
K011548 CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 Medical Analysis Systems, Inc. JJY Class I 2001-06-18
K011035 DIMENSION DRUG CALIBRATOR, MODEL DC22B Dade Behring, Inc. JIX Class II 2001-06-14
K011250 VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS Ortho-Clinical Diagnostics, Inc. JJX Class I 2001-06-13
K011463 VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS Ortho-Clinical Diagnostics JJX Class I 2001-06-13
K011113 HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) Sebia CIN Class II 2001-06-13
K011494 LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL Bio-Rad JJY Class I 2001-06-08
K011057 INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX OraSure Technologies, Inc. PJD Class II 2001-06-06
K010429 ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 Beckman Coulter, Inc. MMI Class II 2001-06-05
K010877 CHEMWELL, MODEL 2900 Awareness Technology, Inc. CIX Class II 2001-05-23
K010864 ANALYST PANELS + ANALYTICAL TEST ROTOR Hemagen Diagnostics, Inc. KHS Class II 2001-05-21
K011169 HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 International Enzymes, Inc. JJY Class I 2001-05-18
K011233 MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 Apex BioTechnology Corp. CGA Class II 2001-05-18
K011213 MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM Beckman Coulter, Inc. JGS Class II 2001-05-16
K003609 N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 Osteometer Biotech A/S NEO Class II 2001-05-16
K010696 BECKMAN COULTER DNASE B CALIBRATOR Beckman Coulter, Inc. JIS Class II 2001-05-10
K010520 GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS Instrumentation Laboratory CO CGA Class II 2001-05-07
K010605 ATLAST DATA MANAGEMENT SOFTWARE (DMS) Amira Medical, Inc. CGA Class II 2001-05-07
K010244 SURE CHECK OVULATION PREDICTOR Chembio Diagnostic Systems, Inc. CEP Class I 2001-05-02
K011126 RAICHEM CREATININE URINE STANDARD Hemagen Diagnostics, Inc. JIT Class II 2001-05-02
K004038 TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 Scantibodies Laboratory, Inc. CEW Class II 2001-04-30
K004010 ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS Roche Diagnostics Corp. LFR Class II 2001-04-26
K003987 URS-1K (KETONE TESST) Teco Diagnostics JIN Class I 2001-04-26
K010670 PICCOLO CHLORIDE TEST SYSTEM Abaxis, Inc. CHJ Class II 2001-04-26
K010314 DIMENSION CTNI CALIBRATOR Dade Behring, Inc. JIT Class II 2001-04-20
K010313 DIMENSION CTNI FLEX REAGENT CARTRIDGE Dade Behring, Inc. MMI Class II 2001-04-20
K010421 WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 Wiener Laboratories Saic KNK Class I 2001-04-13
K010693 VIGIL DNASE B CONTROL Beckman Coulter, Inc. JJX Class I 2001-04-11
K010488 ATAC PAK AST REAGENT KIT Elan Holdings, Inc. CIT Class II 2001-04-09
K010328 MULTIPLE (IZON DNA BLOOD COLLECTION KIT) Izon Business Products, Inc. PJE Class II 2001-04-09
K010593 SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT Sa Scientific, Inc. JHI Class II 2001-04-05
K010652 SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 Sigma Diagnostics, Inc. JIX Class II 2001-03-30
K010201 BAYER ADVIA IMS SYSTEM Bayer Corp. MMI Class II 2001-03-29
K010403 PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 Home Diagnostics, Inc. NBW Class II 2001-03-26
K003752 BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) Biosafe Laboratories, Inc. JLW Class II 2001-03-23
K003835 JAS MAGNESIUM REAGENT Jas Diagnostics, Inc. JGJ Class I 2001-03-23
K003846 ACCU-CHEK INFORM METER Roche Diagnostics Corp. LFR Class II 2001-03-19
K003584 NEOLYNX SCREENING APPLICATION MANAGER Micromass, Inc. JNB Class II 2001-03-19
K010052 RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER Respironics, Inc. MQM Class I 2001-03-19
K010206 DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 Dade Behring, Inc. KHS Class II 2001-03-16
K010266 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 Biosite Incorporated NBC Class II 2001-03-16
K003346 RANDOX GLUCOSE (GOD/PAP) Randox Laboratories, Ltd. CGA Class II 2001-03-15
K003501 N PROTEIN STANDARD UY CALIBRATOR Dade Behring, Inc. JIT Class II 2001-03-15
K010061 DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND Dade Behring, Inc. CEM Class II 2001-03-14
K003503 N LATEX CYSTATIN C Dade Behring, Inc. NDY Class II 2001-03-13
K010428 ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 Beckman Coulter, Inc. JJX Class I 2001-03-13
K010562 ALPHA DX SYSTEM First Medical, Inc. MMI Class II 2001-03-13
K010362 ACCU-CHEK COMFORT CURVE TEST STRIP Roche Diagnostics Corp. LFR Class II 2001-03-07
K010358 VIGIL SEROLOGY CONTROL LEVEL C Beckman Coulter, Inc. JJY Class I 2001-03-05
K003411 ELECSYS TESTOSTERONE CALSET II Roche Diagnostics Corp. JIT Class II 2001-03-01
K010111 CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK Medical Analysis Systems, Inc. JJY Class I 2001-02-28
K003912 PHOSPHORUS REAGENT Jas Diagnostics, Inc. CEO Class I 2001-02-21
K003856 EZ-HCG URINE(PREGNANCY TEST) Biomerica, Inc. JHI Class II 2001-02-21
K010208 DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 Dade Behring, Inc. JIT Class II 2001-02-20
K003892 TOTAL BILIRUBIN REAGENT Intersect Systems, Inc. CIG Class II 2001-02-20
K010030 LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR Synergent Biochem Inc.-Clinical Controls Div. JIX Class II 2001-02-14
K010237 ELECSYS HCG+B CALCHECK Roche Diagnostics Corp. JJX Class I 2001-02-14
K003664 DELFIA NEONATAL IRT KIT, MODEL A005-110 Wallac OY CGZ Class II 2001-02-14
K004002 IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) Diagnostic Products Corp. JHX Class II 2001-02-14
K003668 AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 Wallac OY CGZ Class II 2001-02-12
K003829 TOTAL BILIRUBIN Jas Diagnostics, Inc. CIG Class II 2001-02-12
K003597 IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 Diagnostic Products Corp. LPS Class II 2001-02-05
K010050 ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY Bayer Diagnostics Corp. CGN Class II 2001-02-05
K002407 EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER Medica Corp. JGS Class II 2001-02-02
K002688 PERSONAL GLUCOSE CONTROL CHARTING SYSTEM Lxn Corp. CGA Class II 2001-02-01
K003693 DIRECT BILIRUBIN Jas Diagnostics, Inc. CIG Class II 2001-01-29
K003409 ELECSYS FSH CALSET II Roche Diagnostics Corp. JIT Class II 2001-01-26
K003941 ELECSYS HCG STAT CLASET II Roche Diagnostics Corp. JIS Class II 2001-01-25
K003696 STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD Dade Behring, Inc. DHA Class II 2001-01-25
K002624 GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp. CGA Class II 2001-01-22
K002621 GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp. CGA Class II 2001-01-22
K003174 ELECSYS DHEA-S Roche Diagnostics Corp. JKC Class I 2001-01-17
K002638 FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT Future Diagnostics B.V. CKG Class II 2001-01-17
K003969 ELECSYS CA 125 II CALSET Roche Diagnostics Corp. JIS Class II 2001-01-12
K002450 GENUA MENOPAUSE MONITOR TEST KIT Genua 1944, Inc. CGJ Class I 2001-01-12
K003967 CA 125 II CALCHECK Roche Diagnostics Corp. JJX Class I 2001-01-12
K003257 EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION Cybercare Technologies, Inc. CGA Class II 2000-12-22
K003196 SYNCHRON SYSTEMS AMMONIA REAGENT Beckman Coulter, Inc. JIF Class I 2000-12-22
K003772 ELECSYS DHEA-S CALCHECK Roche Diagnostics Corp. JJX Class I 2000-12-20
K003716 CONFORMANCE CHEMISTRY CONTROL C3 Consolidated Technology JJY Class I 2000-12-20
K002738 BAYER RAPIDPOINT 400 SYSTEM Bayer Corp. CHL Class II 2000-12-19
K002156 APPRAISE URINE MICROALBUMIN COLLECTION KIT Osborn Group, Inc. CGX Class II 2000-12-19
K001441 SATURN BLOOD GLUCOSE MONITORING TEST STRIP Lifescan, Inc. CGA Class II 2000-12-18
K003721 MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. JJE Class I 2000-12-18
K003158 ROCHE DIAGNOSTICS CK-MB Roche Diagnostics Corp. JHW Class II 2000-12-18
K003247 CREATININE Jas Diagnostics, Inc. CGX Class II 2000-12-14
K003178 ELECSYS HCG AND BETA TEST SYSTEM Roche Diagnostics Corp. DHA Class II 2000-12-14
K003327 ALBUMIN Jas Diagnostics, Inc. CIX Class II 2000-12-05
K000582 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 Abbott Diabetes Care, Inc. LFR Class II 2000-12-05
K002128 ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 Diagnostic Systems Laboratories, Inc. NDR Class I 2000-12-05
K003242 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 Bio-Rad JJS Class I 2000-11-30
K003096 FASTPACK CALIBRATORS Qualigen, Inc. JIT Class II 2000-11-30
K003239 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 Bio-Rad JJS Class I 2000-11-30
K003095 FASTPACK CONTROL Qualigen, Inc. JJX Class I 2000-11-29

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