Home / 510(k) Clearances / K983132

510(k) K983132

IGM by Abbott Laboratories — Product Code DFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1998
Date Received
September 8, 1998
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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