CK-NUC REAGENT

Differential Rate Kinetic Method, Cpk Or Isoenzymes

SMITH KLINE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Ck-nuc Reagent.

Pre-market Notification Details

Device IDK790916
510k NumberK790916
Device Name:CK-NUC REAGENT
ClassificationDifferential Rate Kinetic Method, Cpk Or Isoenzymes
Applicant SMITH KLINE DIAGNOSTICS, 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 Received1979-05-14
Decision Date1979-06-22

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