meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
46
Latest Decision
2006-06-06

Clearances · page 23 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K060632 VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 Ortho-Clinical Diagnostics, Inc. NBC Class II 2006-06-06
K052469 GLUCOPACK Healthpia America Corp. NBW Class II 2006-06-05
K061282 ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 Beckman Coulter, Inc. JIT Class II 2006-06-02
K061251 DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR Dade Behring, Inc. JIS Class II 2006-05-31
K061196 CARDIOIMMUNE XL CARDIAC MARKER CONTROL Microgenics Corp. JJY Class I 2006-05-30
K060850 NOD CHEMISTRY CONTROL Bioresource Technology, Inc. JJY Class I 2006-05-30
K061238 DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE Dade Behring, Inc. KHS Class II 2006-05-25
K061182 CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB Cliniqa Corporation JJY Class I 2006-05-25
K053452 PURE-AID PREGNANCY TEST Bio Focus Co., Lt. LCX Class II 2006-05-25
K060128 CLEARBLUE EASY DIGITAL PREGNANCY TEST Unipath , Ltd. LCX Class II 2006-05-25
K060964 ARCHITECT BNP ASSAY, MODEL 8K28 Fujirebio Diagnostics,Inc. NBC Class II 2006-05-25
K061118 ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. NBW Class II 2006-05-19
K060502 DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 Dade Behring, Inc. MLM Class II 2006-05-18
K061048 COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM Roche Diagnostics Corp. CFR Class II 2006-05-17
K061020 DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE Dade Behring, Inc. CKA Class I 2006-05-10
K060383 GLUCOSE Abbott Laboratories CFR Class II 2006-05-05
K060295 CARBON DIOXIDE Abbott Laboratories KHS Class II 2006-05-04
K060585 ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH Roche Diagnostics Corp. CKG Class II 2006-05-03
K060574 TOTAL BILIRUBIN Abbott Laboratories CIG Class II 2006-05-03
K060929 IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 Diagnostic Products Corporation CDD Class II 2006-04-28
K060706 LIBERTY NORMAL GLUCOSE CONTROL SOLUTION Liberty Healthcare Group, Inc. JJX Class I 2006-04-28
K060935 SYNCHRON SYSTEMS CREATININE (CREA) REAGENT Beckman Coulter, Inc. CGX Class II 2006-04-28
K060345 NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS Nova Biomedical Corp. CGA Class II 2006-04-28
K053612 DRI-STAT ACID PHOSPHATASE REAGENT Beckman Coulter, Inc. CKB Class II 2006-04-26
K060140 CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 Diagnostic Chemicals , Ltd. JIT Class II 2006-04-24
K060940 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III Ortho-Clinical Diagnostics, Inc. JIX Class II 2006-04-24
K060774 FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 Beckman Coulter, Inc. CGN Class II 2006-04-21
K060768 PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS Abbott Diabetes Care, Inc. JIN Class I 2006-04-21
K060754 ELECSYS TSH CALSET W/MODELS 04738551 Roche Diagnostics Corp. JIT Class II 2006-04-18
K053577 DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT Dade Behring, Inc. MMI Class II 2006-04-14
K051651 G4, MODEL IGM-0004 U. S. Diagnostics, Inc. NBW Class II 2006-04-14
K060359 ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 Denka Seiken Co., Ltd. JIT Class II 2006-04-14
K060570 HEMOGLOBIN ALC CONTROL Compass Bioscience JJX Class I 2006-04-13
K060470 ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 Bayer Healthcare NBW Class II 2006-04-12
K060755 ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK Roche Diagnostics Corp. CDD Class II 2006-04-10
K060628 DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR Dade Behring, Inc. CIG Class II 2006-04-06
K060548 STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK Dade Behring, Inc. DHA Class II 2006-04-06
K060385 EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT Dade Behring, Inc. MLM Class II 2006-04-06
K050988 OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. DLG Class I 2006-04-06
K060617 PTS PANELS HDL CHOLESTEROL TEST STRIPS Polymer Technology Systems, Inc. NAQ Class I 2006-04-05
K052794 ETI-MAX 3000 DiaSorin, Inc. JJF Class I 2006-03-31
K052914 RX IMOLA Randox Laboratories, Ltd. CEM Class II 2006-03-31
K052788 N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H Dade Behring, Inc. LPS Class II 2006-03-29
K052525 CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS DFI Co., Ltd. JIL Class II 2006-03-29
K053079 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 Hypoguard USA, Inc. CGA Class II 2006-03-28
K060120 TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM Teco Diagnostics CDQ Class II 2006-03-27
K053401 SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS Arkray, Inc. CIC Class II 2006-03-24
K060215 ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 Eurotrol B.V. JJX Class I 2006-03-24
K060322 CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED Cliniqa Corporation JIT Class II 2006-03-21
K060206 MISSION COMPLETE Diamond Diagnostics, Inc. JJY Class I 2006-03-21
K060429 TDM CONTROL SET Roche Diagnostics Corp. JJY Class I 2006-03-15
K060373 COBAS 6000 SERIES SYSTEM Roche Diagnostics CEM Class II 2006-03-13
K051596 STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204 Nanogen, Inc. NBC Class II 2006-03-13
K053291 FERRITIN CALIBRATOR SET, CATALOG NO. 8203 Reference Diagnostics, Inc. JIT Class II 2006-03-13
K060426 LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041 Liberty Healthcare Group, Inc. JJX Class I 2006-03-09
K052207 ACCUREX GLUCOSE TEST STRIP Incline Medical, LLC CGA Class II 2006-03-09
K060481 LIBERTY GLUCOSE CONTROL SOLUTION Liberty Healthcare Group, Inc. JJX Class I 2006-03-09
K060371 THE EMIT 2000 TACROLIMUS CALIBRATORS Dade Behring, Inc. JIT Class II 2006-03-09
K060266 DIMENSION IRON CALIBRATOR Dade Behring, Inc. JIS Class II 2006-03-09
K051839 FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 Abbott Diabetes Care, Inc. NBW Class II 2006-03-09
K060264 DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) Dade Behring, Inc. JIY Class I 2006-03-08
K053531 DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR Dade Behring, Inc. CEC Class II 2006-03-03
K050975 NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN Nano-Ditech Co. MMI Class II 2006-03-02
K053312 EASYMATE BLOOD GLUCOSE MONITORING SYSTEM Bioptik Technology, Inc. NBW Class II 2006-03-01
K053138 MYSET PREGNANCY TEST Ani Biotech OY LCX Class II 2006-03-01
K060420 MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 Scantibodies Laboratory, Inc. CEW Class II 2006-03-01
K060256 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM Beckman Coulter, Inc. CFR Class II 2006-02-27
K060348 MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT Scantibodies Laboratory, Inc. CEW Class II 2006-02-27
K060090 DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE Dade Behring, Inc. JLW Class II 2006-02-27
K053635 MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM Bionime Corporation NBW Class II 2006-02-21
K060019 ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) Artron Laboratories, Inc. LCX Class II 2006-02-17
K053253 HEMOCUE ALBUMIN 201 ANALYZING SYSTEM Hemocue AB KQO Class I 2006-02-17
K060133 ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET Inverness Medical Innovations, Inc. JJX Class I 2006-02-16
K060108 COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 Roche Diagnostics Corp. CGZ Class II 2006-02-16
K053566 MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A Diazyme Laboratories MZV Class II 2006-02-15
K053576 DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR Dade Behring, Inc. JIT Class II 2006-02-07
K053061 EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY Dade Behring, Inc. MKW Class II 2006-02-06
K053533 IMMULITE/IMMULITE 1000 TURBO INTACT PTH Diagnostic Products Corporation CEW Class II 2006-02-03
K051648 SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS Arkray, Inc. CGS Class II 2006-01-31
K052649 DRG SLV TESTOSTERONE ELISA TEST Drg Intl., Inc. CDZ Class I 2006-01-27
K060027 ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) Biokit, S.A. JJX Class I 2006-01-26
K051447 SENTINEL PANCREATIC AMYLASE Sentinel Ch. Srl JFJ Class II 2006-01-26
K053327 OXICOM CONTROL Bionostics, Inc. JJX Class I 2006-01-26
K052762 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 Agamatrix, Inc. NBW Class II 2006-01-23
K052789 TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 Biosite Incorporated NBC Class II 2006-01-23
K050955 LIFESIGN DXPRESS, MODEL LSR2000 Princeton BioMeditech Corp. JHI Class II 2006-01-23
K053529 ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. NBW Class II 2006-01-17
K053153 RANDOX CALIBRATION SERUM Randox Laboratories, Ltd. JIX Class II 2006-01-13
K053110 Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge I-Stat Corporation JGS Class II 2006-01-13
K053247 VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET Maine Standards Co. JJY Class I 2006-01-13
K052925 SMARTPREP2 CENTRIFUGE SYSTEM Harvest Technologies, Corp. JQC Class I 2006-01-04
K052301 FASTPACK TSH IMMUNOASSAY Qualigen, Inc. JLW Class II 2006-01-04
K053020 TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Healthcare, LLC MMI Class II 2005-12-30
K053132 WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 Wako Chemicals USA, Inc. JFM Class II 2005-12-30
K053131 WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 Wako Chemicals USA, Inc. JFM Class II 2005-12-30
K052867 VITROS CHEMISTRY PRODUCTS DTIBC REAGENT Ortho-Clinical Diagnostics, Inc. JMO Class I 2005-12-23
K053104 DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR Dade Behring, Inc. JIS Class II 2005-12-23
K053330 ARCHITECT B12 CALIBRATORS Abbott Laboratories JIT Class II 2005-12-16
K053090 DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR Beckman Coulter, Inc. JFM Class II 2005-12-16
K052694 ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. Ind Diagnostic, Inc. JHI Class II 2005-12-16

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