AMMONIA TEST— 510(k) K813366

Name: FDA 510(k) clearance K813366
Creator: U.S. Food and Drug Administration
Published: 1981-12-22

Substantially Equivalent

Wako Pure Chemical Industries, Ltd.

FDA 510(k) clearance K813366 for AMMONIA TEST, Substantially Equivalent on 1981-12-22. Applicant: Wako Pure Chemical Industries, Ltd.. Device class: 1.

Clearance details

Applicant: Wako Pure Chemical Industries, Ltd.
Product code: Code JID
Device class: Class 1
Regulation: 21 CFR 862.1065
Advisory panel: Clinical Chemistry
Date received: 1981-11-30
Decision date: 1981-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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