GLYCATED PROTEIN CALIBRATORS— 510(k) K940008

Substantially Equivalent

Primus Corp.

FDA 510(k) clearance K940008 for GLYCATED PROTEIN CALIBRATORS, Substantially Equivalent on 1994-05-09. Applicant: Primus Corp.. Device class: 2.

Clearance details

Applicant: Primus Corp.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1994-01-04
Decision date: 1994-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

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