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510(k) K812076

ANTI-GM & ANTI-KM TYPING SERUMS by Biotest-Serum-Institut — Product Code DGH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 12, 1981
Date Received: July 22, 1981
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Igd, Peroxidase, Antigen, Antiserum, Control
Device Class: Class II
Regulation Number: 866.5510
Review Panel: PA
Submission Type