ALKALINE PHOSPHATASE REAGENT SYSTEM— 510(k) K952746

Name: FDA 510(k) clearance K952746
Creator: U.S. Food and Drug Administration
Published: 1995-11-27

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K952746 for ALKALINE PHOSPHATASE REAGENT SYSTEM, Substantially Equivalent on 1995-11-27. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1995-06-16
Decision date: 1995-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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