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510(k) K872834

TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 by Helena Laboratories — Product Code CZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1987
Date Received
July 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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