Blood Bank Supplies

Supplies, Blood-bank

Gamma Biologicals, Inc.

The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Blood Bank Supplies.

Pre-market Notification Details

Device IDBK970002
510k NumberBK970002
Device Name:Blood Bank Supplies
ClassificationSupplies, Blood-bank
Applicant Gamma Biologicals, Inc. 3700 Mangum Road Houston,  TX  77092
Product CodeKSS  
CFR Regulation Number864.9050 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-10
Decision Date1997-05-30

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