NML CK-MB RIA

Fluorometric Method, Cpk Or Isoenzymes

NUCLEAR MEDICAL LABORATORIES, INC.

The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Nml Ck-mb Ria.

Pre-market Notification Details

Device IDK812759
510k NumberK812759
Device Name:NML CK-MB RIA
ClassificationFluorometric Method, Cpk Or Isoenzymes
Applicant NUCLEAR MEDICAL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHX  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-10-01
Decision Date1981-10-19

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