FDA 510(k) Application Details - K191296

Device Classification Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K191296
Device Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant	MedTest Dx 5449 Research Drive Canton, MI 48188 US Other 510(k) Applications for this Company
Contact	William Cripps Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	CGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2019
Decision Date	08/11/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review