510(k) K800658

RST-SERIES CONTROL by Gamma Biologicals, Inc. — Product Code KSF

K800658 is an FDA 510(k) premarket notification submitted by Gamma Biologicals, Inc. for the device "RST-SERIES CONTROL". The FDA issued a decision of Substantially Equivalent on April 16, 1980. The device falls under product code KSF (Kit, Quality Control For Blood Banking Reagents), a Class II device regulated under 21 CFR 864.9650. Gamma Biologicals, Inc. has at least 10 other 510(k) clearances on record.