GEMENI CK-MB ISOENZYME ABNORMAL SERUM

Enzyme Controls (assayed And Unassayed)

GEMINI, INC.

The following data is part of a premarket notification filed by Gemini, Inc. with the FDA for Gemeni Ck-mb Isoenzyme Abnormal Serum.

Pre-market Notification Details

Device IDK810870
510k NumberK810870
Device Name:GEMENI CK-MB ISOENZYME ABNORMAL SERUM
ClassificationEnzyme Controls (assayed And Unassayed)
Applicant GEMINI, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJT  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-31
Decision Date1981-04-14

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