U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST— 510(k) K863980

Name: FDA 510(k) clearance K863980
Creator: U.S. Food and Drug Administration
Published: 1986-12-04

Substantially Equivalent

U. S. Diagnostics, Inc.

FDA 510(k) clearance K863980 for U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST, Substantially Equivalent on 1986-12-04. Applicant: U. S. Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: U. S. Diagnostics, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1986-10-14
Decision date: 1986-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Luis Obispo, CA, US

Download summary PDF View on FDA.gov ↗

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