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510(k) K873871

IMMUNOGLOBULINS M by Unipath , Ltd. — Product Code DFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1987
Date Received
August 24, 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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