BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY— 510(k) K913091

Name: FDA 510(k) clearance K913091
Creator: U.S. Food and Drug Administration
Published: 1991-08-26

Substantially Equivalent

American Laboratory Products Co., Ltd.

FDA 510(k) clearance K913091 for BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY, Substantially Equivalent on 1991-08-26. Applicant: American Laboratory Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: American Laboratory Products Co., Ltd.
Product code: Code KQN
Device class: Class 2
Regulation: 21 CFR 862.1090
Advisory panel: Clinical Chemistry
Date received: 1991-07-12
Decision date: 1991-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, US

Download summary PDF View on FDA.gov ↗

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