FLOW-PAC ALKALINE PHOSPHATE REAGENT SET— 510(k) K830535

Name: FDA 510(k) clearance K830535
Creator: U.S. Food and Drug Administration
Published: 1983-03-24

Substantially Equivalent

Amresco, Inc.

FDA 510(k) clearance K830535 for FLOW-PAC ALKALINE PHOSPHATE REAGENT SET, Substantially Equivalent on 1983-03-24. Applicant: Amresco, Inc.. Device class: 2.

Clearance details

Applicant: Amresco, Inc.
Product code: Code CJF
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 1983-02-18
Decision date: 1983-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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