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510(k) K014084

NYCOCARD CRP CONTROL by Primus Corp. — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2002
Date Received
December 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

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  • K942009 — PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY (September 14, 1994)
  • K940008 — GLYCATED PROTEIN CALIBRATORS (May 9, 1994)
  • K940142 — GLYCATED PROTEIN CONTROLS (April 26, 1994)
  • K936204 — GLYCATED HEMOGLOBIN CALIBRATORS (March 22, 1994)

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