G-GT REAGENT— 510(k) K851999

Substantially Equivalent

Alpkem Corp.

FDA 510(k) clearance K851999 for G-GT REAGENT, Substantially Equivalent on 1985-06-10. Applicant: Alpkem Corp.. Device class: 1.

Clearance details

Applicant: Alpkem Corp.
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1985-05-07
Decision date: 1985-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

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