ULTRAZYME PLUS CK-I

Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

HARLECO DIAGNOSTICS

The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Ultrazyme Plus Ck-i.

Pre-market Notification Details

Device IDK821883
510k NumberK821883
Device Name:ULTRAZYME PLUS CK-I
ClassificationNad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Applicant HARLECO DIAGNOSTICS 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 Received1982-06-25
Decision Date1982-07-14

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