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510(k) K940143

GLYCATED HEMOGLOBIN CONTROLS by Primus Corp. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1994
Date Received
January 11, 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

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  • 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)
  • 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)

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