510(k) K780203

THROMBOPLASTIN DRIED by Hyland Therapeutic Div., Travenol Laboratories — Product Code GJS

K780203 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "THROMBOPLASTIN DRIED". The FDA issued a decision of Substantially Equivalent on March 27, 1978. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.