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510(k) K862762

TINA-QUANT(R) IGM by Boehringer Mannheim Corp. — Product Code DFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1986
Date Received
July 22, 1986
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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