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510(k) K891235

PRIMUS MODEL CLC 330 by Primus, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1989
Date Received
March 7, 1989
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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  • 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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