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510(k) K780325

RID SYSTEM-HUMAN C-REACTIVE PROTEIN by Icl Scientific — Product Code DEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1978
Date Received
February 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5420
Review Panel
IM
Submission Type

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Other clearances for product code DEN

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