DURAZYME GPT/ALT— 510(k) K800115

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K800115 for DURAZYME GPT/ALT, Substantially Equivalent on 1980-02-13. Applicant: American Monitor Corp..

Clearance details

Applicant: American Monitor Corp.
Product code: Code CKA
Advisory panel: Clinical Chemistry
Date received: 1980-01-18
Decision date: 1980-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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