BICARBONATE REAGENTS AMRESCO PRODUCT #4326020— 510(k) K904007

Name: FDA 510(k) clearance K904007
Creator: U.S. Food and Drug Administration
Published: 1990-09-13

Substantially Equivalent

Amresco, Inc.

FDA 510(k) clearance K904007 for BICARBONATE REAGENTS AMRESCO PRODUCT #4326020, Substantially Equivalent on 1990-09-13. Applicant: Amresco, Inc.. Device class: 2.

Clearance details

Applicant: Amresco, Inc.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1990-08-29
Decision date: 1990-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

Download summary PDF View on FDA.gov ↗

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