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510(k) K994045

PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 by Primus Corp. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1999
Date Received
November 29, 1999
Clearance Type
Special
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

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  • K993131 — NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY (May 22, 2000)
  • K992921 — PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II (November 12, 1999)
  • K955283 — PRIMUS VARIANT SYSTEM PVS99 (March 1, 1996)
  • 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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