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510(k) K790710

ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN by Kent Laboratories, Inc. — Product Code DDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1979
Date Received
April 12, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5620
Review Panel
IM
Submission Type

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