GEMENI QUICK-MB SEPARATION KIT

Chromatographic Separation, Cpk Isoenzymes

GEMINI, INC.

The following data is part of a premarket notification filed by Gemini, Inc. with the FDA for Gemeni Quick-mb Separation Kit.

Pre-market Notification Details

Device IDK810534
510k NumberK810534
Device Name:GEMENI QUICK-MB SEPARATION KIT
ClassificationChromatographic Separation, Cpk Isoenzymes
Applicant GEMINI, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHT  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-02-26
Decision Date1981-03-11

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