meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
42
Latest Decision
2014-01-17

Clearances · page 11 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133197 FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE Fujirebio Diagnostics,Inc. JJX Class I 2014-01-17
K132739 IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics, Inc. JJX Class I 2014-01-14
K133407 GEM PREMIER 4000 Instrumentation Laboratory CO CHL Class II 2014-01-13
K133302 FLEXMAP 3D Luminex Corp. NSU Class II 2014-01-10
K132834 FASTEP S10 HCG SERUM/URINE COMBO TEST Polymed Therapeutics, Inc. JHI Class II 2014-01-09
K131554 RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT Randox Laboratories, Ltd. JJE Class I 2014-01-09
K123986 ACTIM PROM Alere Scarborough, Inc. OAM Class I 2014-01-09
K131469 ACON ON CALL DIABETES MANAGEMENT SOFTWARE ACON Laboratories, Inc. NBW Class II 2014-01-06
K132399 ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL Elitechgroup JFY Class II 2014-01-03
K133512 LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) Siemens Healthcare Diagnostics CDD Class II 2014-01-02
K123763 IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS Immunodiagnostic Systems , Ltd. CIB Class II 2013-12-24
K132511 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM Abbott Diabetes Care, Inc. NBW Class II 2013-12-24
K130284 ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM ACON Laboratories, Inc. NBW Class II 2013-12-20
K132400 LP(A) CALIBRATORS, AND LP(A) CONTROLS Biokit, S.A. JIT Class II 2013-12-19
K132086 ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM ACON Laboratories, Inc. NBW Class II 2013-12-19
K133346 SMARTLOG DIABETES MANAGEMENT SOFTWARE I-Sens, Inc. NBW Class II 2013-12-19
K132418 COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 Roche Diagnostics JGS Class II 2013-12-18
K132862 HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM Infopia Co, Ltd. NBW Class II 2013-12-12
K132966 GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM Infopia Co, Ltd. NBW Class II 2013-12-05
K132828 ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 Roche Diagnostics JKR Class II 2013-12-04
K122340 PRODIGY CHOICE Prodigy Diabetes Care, LLC NBW Class II 2013-11-26
K133330 C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN Roche Diagnostics JIX Class II 2013-11-26
K133067 ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT Siemens Healthcare Diagnostics, Inc. CDT Class I 2013-11-22
K133284 ELECSYS CK-MB CALCHECK 5 Roche Diagnostics JJX Class I 2013-11-22
K132288 CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER I-Sens, Inc. NBW Class II 2013-11-22
K123090 GLB BENECHECK PREMIUM GLU MONITORING SYSTEM General Life Biotechnology Co., Ltd. NBW Class II 2013-11-22
K132066 INFLAMMA DRY Rapid Pathogen Screening, Inc. PFQ Class I 2013-11-21
K123977 RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR Randox Laboratories, Ltd. CGS Class II 2013-11-21
K132821 AGAMATRIX HEALTH MANAGER Agamatrix, Inc. NBW Class II 2013-11-20
DEN130042 MISEQDX UNIVERSAL KIT 1.0 Illumina, Inc. PFT Class I 2013-11-19
K131284 GSP NEONATAL BIOTINIDASE KIT Wallac OY NAK Class II 2013-11-14
K132085 ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM Co-Innovation Biotech Co., Ltd. LCX Class II 2013-11-12
K132515 LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS DiaSorin, Inc. CEW Class II 2013-11-08
K131236 UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP Ucp Biosciences, Inc. LCX Class II 2013-11-07
K113135 UNISTRIP 1 Unistrip Technologies, LLC NBW Class II 2013-11-06
K122338 PREFERRED BLOOD GLUCOSE MONITORING SYSTEM Prodigy Diabetes Care, LLC NBW Class II 2013-11-05
K133122 IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) Siemens Healthcare Diagnostics, Inc. JJX Class I 2013-10-30
K132462 S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE Hitachi Chemical Diagnostics, Inc. CDN Class II 2013-10-28
K133124 IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA Siemens Healthcare Diagnostics, Inc. JJX Class I 2013-10-25
K132227 LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY Bio-Rad Laboratories JJY Class I 2013-10-25
K133003 RIGHTEST CONTROL SOLUTION Bionime Corporation JJX Class I 2013-10-24
K132338 DA01 BLOOD GLUCOSE MONITORING SYSTEM Delbio Incorporation NBW Class II 2013-10-24
K132156 RANDOX CSF CONTROLS LEVELS 2 AND 3 Randox Laboratories, Ltd. JJY Class I 2013-10-23
K133128 IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION Siemens Healthcare Diagnostics, Inc. JJX Class I 2013-10-22
K132751 MULTICHEM S PLUS / S PLUS (ASSAYED) Techno-Path Manufacturing , Ltd. JJY Class I 2013-10-22
K132571 ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY Roche Diagnostics JHY Class II 2013-10-18
K132272 GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION Glooko, Inc. NBW Class II 2013-10-17
K131013 FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM Nova Biomedical Corporation NBW Class II 2013-10-17
K132664 ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR Siemens Healthcare Diagnostics, Inc. CJW Class II 2013-10-16
K131993 MULTICHEM U Techno-Path Manufacturing , Ltd. JJY Class I 2013-10-15
K131366 ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics Operations, Inc. LFR Class II 2013-10-11
K131662 IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics, Inc. JJX Class I 2013-10-10
K131546 AU BICARBONATE REAGENT Beckman Coulter Ireland, Inc. KHS Class II 2013-10-09
K131479 V8 SP NORMAL CONTROL, ABNORMAL CONTROL Helena Laboratories JJY Class I 2013-10-07
K130628 PATHFAST CK-MB-II CALIBRATORS Mitsubishi Chemical Medience Corporation JIT Class II 2013-10-04
K131975 ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT Alfa Wassermann Diagnostic Technologies, Inc. CFJ Class II 2013-10-02
K130020 ACCESS TOTAL BHCG (5TH IS) Beckman Coulter, Inc. DHA Class II 2013-10-01
K122370 CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR Bayer Healthcare NBW Class II 2013-09-26
K131992 MULTICHEM P Techno-Path Manufacturing , Ltd. JJY Class I 2013-09-25
K121790 ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM Beckman Coulter, Inc. MMI Class II 2013-09-25
K132091 MULTICHEM IA AND IA PLUS Techno-Path Manufacturing , Ltd. JJY Class I 2013-09-20
K132391 IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL Siemens Helathcare Diagnostics, Inc. JJX Class I 2013-09-20
K131988 ABL90 FLEX ANALYZER Radiometer Medical Aps CHL Class II 2013-09-17
K132249 ADVIA CENTAUR FT4, ADVIA CENTAUR T4 Siemens Healthcare Diagnostics, Inc. CEC Class II 2013-09-13
K123567 FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST Church & Dwight Co., Inc. LCX Class II 2013-09-10
K131037 LIAISON XL HCG DiaSorin, Inc. DHA Class II 2013-09-06
K132492 LIAISON 25 TOTAL-D DiaSorin, Inc. MRG Class II 2013-09-05
K131363 ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM Cilag GmbH International NBW Class II 2013-08-30
K123987 IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET Innovative Medical Technologies, Inc. JKA Class II 2013-08-27
K123436 FIRST RESPONSE EARLY RESULT PREGNANCY TEST Church & Dwight Co., Inc. LCX Class II 2013-08-26
K130244 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM Delbio Incorporation NBW Class II 2013-08-23
K122355 VANISHPOINT BLOOD COLLECTION SET Retractable Technologies, Inc. JKA Class II 2013-08-23
K131126 OPTI CCA-TS2 Opti Medical Systems, Inc. CHL Class II 2013-08-22
K130696 CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM I-Sens, Inc. NBW Class II 2013-08-21
K131488 ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT Alfa Wassermann Diagnostics Technologies, LLC CIX Class II 2013-08-19
K132072 TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM Nipro Diagnostics, Inc. NBW Class II 2013-08-15
K131351 ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT Alfa Wassermann Diagnostic Technologies, LLC CJE Class II 2013-08-15
K122181 EBCHEK BLOOD GLUCOSE MONITORING SYSTEM Visgeneer, Inc. NBW Class II 2013-08-15
K131515 ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT Alfa Wassermann KLI Class II 2013-08-14
K131536 IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics, Inc. JJX Class I 2013-08-12
K130685 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY Hitachi Chemical Diagnostics, Inc. JFJ Class II 2013-08-09
K131029 ACCU-CHEK AVIVA PLUS TEST STRIP Roche Diagnostics Operations, Inc. NBW Class II 2013-08-09
K131419 ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM I-Sens, Inc. NBW Class II 2013-08-09
K121610 COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY Roche Diagnostics Operations PDJ Class II 2013-08-08
K131166 SOFIA(R) HCG FIA Quidel Corp. JHI Class II 2013-08-02
K131301 BD FACS SAMPLE PREP ASSISTANT III Becton, Dickinson & CO PER Class I 2013-08-02
K130144 ABL90 FLEX Radiometer Medical Aps CHL Class II 2013-07-31
K130181 GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM Infopia Co, Ltd. NBW Class II 2013-07-31
K130621 BROADMASTER HEALTHCARE SYSTEM Broadmaster Biotech Corporation NBW Class II 2013-07-30
K131931 CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST Chemtron Biotech, Inc. LCX Class II 2013-07-26
K131595 EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM Eurotrol B.V. JJY Class I 2013-07-26
K131999 HBA1C CONTROL, LEVEL 1 AND LEVEL 2 Randox Laboratories, Ltd. JJX Class I 2013-07-26
K130500 CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT Sebia CEF Class I 2013-07-26
K131776 ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 Randox Laboratories, Ltd. JJX Class I 2013-07-18
K131544 COBAS C BILIRUBIN TOTAL GEN.3 Roche Diagnostics CIG Class II 2013-07-17
K123660 25-OH VITAMIN D ELISA Euroimmun US MRG Class II 2013-07-17
K130253 TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION Beckman Coulter, Inc. PER Class I 2013-07-15
K123364 25OH VITAMIN D TOTAL ELISA TEST Diasource Immunoassays, S.A. MRG Class II 2013-07-15
K130657 LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE All Medicus Co., Ltd. NBW Class II 2013-07-15
K123343 THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS Microgenics Corp. MLM Class II 2013-07-11

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