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510(k) K962200

QUANTEX IGA by Instrumentation Laboratory CO — Product Code CZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1996
Date Received
June 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iga, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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