GAMMA LEWIS BLOOD GROUP SUBSTANCE

Substance, Blood Grouping Of Non-human Origin 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 Gamma Lewis Blood Group Substance.

Pre-market Notification Details

Device IDK802533
510k NumberK802533
Device Name:GAMMA LEWIS BLOOD GROUP SUBSTANCE
ClassificationSubstance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use
Applicant GAMMA BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKSX  
CFR Regulation Number864.9160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-15
Decision Date1980-11-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888234000853 K802533 000

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