NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY— 510(k) K993131

Name: FDA 510(k) clearance K993131
Creator: U.S. Food and Drug Administration
Published: 2000-05-22

Substantially Equivalent

Primus, Inc.

FDA 510(k) clearance K993131 for NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY, Substantially Equivalent on 2000-05-22. Applicant: Primus, Inc.. Device class: 2.

Clearance details

Applicant: Primus, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1999-09-20
Decision date: 2000-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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