LO-ION

Media, Potentiating For In Vitro Diagnostic Use

GAMMA BIOLOGICALS, INC.

The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Lo-ion.

Pre-market Notification Details

Device IDK790973
510k NumberK790973
Device Name:LO-ION
ClassificationMedia, Potentiating For In Vitro Diagnostic Use
Applicant GAMMA BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKSG  
CFR Regulation Number864.9600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-05-23
Decision Date1979-06-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888234001775 K790973 000

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