CREATININE REAGENT SET— 510(k) K832439

Substantially Equivalent

Amresco, Inc.

FDA 510(k) clearance K832439 for CREATININE REAGENT SET, Substantially Equivalent on 1984-01-17. Applicant: Amresco, Inc.. Device class: 2.

Clearance details

Applicant: Amresco, Inc.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1983-07-25
Decision date: 1984-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.