CLINICARD CK-II

Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

HARLECO

The following data is part of a premarket notification filed by Harleco with the FDA for Clinicard Ck-ii.

Pre-market Notification Details

Device IDK772258
510k NumberK772258
Device Name:CLINICARD CK-II
ClassificationNad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Applicant HARLECO 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGS  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-12-09
Decision Date1978-01-05

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