NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY— 510(k) K993131

Substantially Equivalent

Primus, Inc.

FDA 510(k) clearance K993131 for NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY, Substantially Equivalent on 2000-05-22. Applicant: Primus, Inc..

Clearance details

Applicant: Primus, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 1999-09-20
Decision date: 2000-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

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