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510(k) K942009

PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY by Primus Corp. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1994
Date Received
April 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

Other clearances by Primus Corp.

  • K062658 — PRIMUS A1CARE ASSAY (November 26, 2007)
  • K013787 — NYCOCARD CRP (May 14, 2002)
  • K014084 — NYCOCARD CRP CONTROL (January 7, 2002)
  • K993131 — NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY (May 22, 2000)
  • K994045 — PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 (December 21, 1999)
  • K992921 — PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II (November 12, 1999)
  • K955283 — PRIMUS VARIANT SYSTEM PVS99 (March 1, 1996)
  • 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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