QUICK CEPT

Differential Rate Kinetic Method, Cpk Or Isoenzymes

LABORATORY DIAGNOSTICS CO., INC.

The following data is part of a premarket notification filed by Laboratory Diagnostics Co., Inc. with the FDA for Quick Cept.

Pre-market Notification Details

Device IDK801668
510k NumberK801668
Device Name:QUICK CEPT
ClassificationDifferential Rate Kinetic Method, Cpk Or Isoenzymes
Applicant LABORATORY DIAGNOSTICS CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHS  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-07-21
Decision Date1980-08-13

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