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510(k) K841814

OPTIMATE IGM TEST by Miles Laboratories, Inc. — Product Code DFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1984
Date Received
May 1, 1984
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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