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510(k) K841114

ALLO-TYPE HUMAN IMMUNOGLOBULIN- by Genetic Testing Institute — Product Code DGX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 14, 1984
Date Received: March 15, 1984
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Ng1m(A), Antigen, Antiserum, Control
Device Class: Class I
Regulation Number: 866.5065
Review Panel: IM
Submission Type