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510(k) K920008

IL TEST IMMUNOGLOBULIN M (IGM) by Instrumentation Laboratory CO — Product Code CGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1992
Date Received
January 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Immunodiffusion, Immunoglobulins (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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Other clearances for product code CGM

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