FDA 510(k) Applications for Medical Device:
U.V. Method, Cpk Isoenzymes

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K961501 BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K122083 ELITECHGROUP 21720 23RD DR SE
BOTHELL WA 98021
K141265 ELITECHGROUP 21720 23RD DR SE
BOTHELL WA 98021
K162526 ROCHE DIAGNOSTICS 9115 HAGUE ROAD
INDIANAPOLIS IN 46250
K003158 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K023744 WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA
ROSARIO 2000




Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact