KINETIC ALKALINE PHOSPHATASE— 510(k) K834033

Name: FDA 510(k) clearance K834033
Creator: U.S. Food and Drug Administration
Published: 1984-01-30

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K834033 for KINETIC ALKALINE PHOSPHATASE, Substantially Equivalent on 1984-01-30. Applicant: American Monitor Corp.. Device class: 2.

Clearance details

Applicant: American Monitor Corp.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1983-11-23
Decision date: 1984-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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