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510(k) K833841

IL TEST IGG IGA & IGM KITS by Instrumentation Laboratory CO — Product Code CZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1984
Date Received
November 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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