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510(k) K191296

Device
Pointe Scientific Creatinine Kinase (CK) Reagent Set
Applicant
Medtest DX
510(k) number
K191296
Product code
CGS
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-11
Date received
2019-05-14
Regulation
862.1215
Classification name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
William Cripps
Address
5449 Research Dr. Lincoln Park MI US 48188 48188

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CGS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.2019-04-17
K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.2016-09-07
K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORRandox Laboratories, Ltd.2013-11-21
K112416CPK REAGENTVital Diagnostics (Manufacturing) Ptyltd2011-11-09
K083465DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics2009-02-27
K081731DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32Siemens Healthcare Diagnostics2008-08-29
K072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440Teco Diagnostics2008-04-18
K062737CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx2007-06-12
K051648SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTSArkray, Inc.2006-01-31
K043202OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279Olympus America, Inc.2004-12-23
K021332WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDAWiener Laboratories Saic2002-07-03
K013912CREATINE KINASE (CK-NAC)Jas Diagnostics, Inc.2002-01-18
K012474ATAC PAK CPK REAGENT KITElan Holdings, Inc.2001-10-03
K994189OLYMPUS CREATINE KINASE REAGENT OSR6179/6279Olympus Diagnostica GmbH2000-01-20
K992148HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KITMorax1999-12-29