GLYCATED HEMOGLOBIN CALIBRATORS— 510(k) K936204

Substantially Equivalent

Primus Corp.

FDA 510(k) clearance K936204 for GLYCATED HEMOGLOBIN CALIBRATORS, Substantially Equivalent on 1994-03-22. Applicant: Primus Corp.. Device class: 2.

Clearance details

Applicant: Primus Corp.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1993-12-29
Decision date: 1994-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.