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510(k) K871498

TITAN GEL IMMUNOFIX CONTROLS by Helena Laboratories — Product Code DFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1987
Date Received
April 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

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