LIPASE REAGENT SYSTEM— 510(k) K940457

Name: FDA 510(k) clearance K940457
Creator: U.S. Food and Drug Administration
Published: 1994-06-02

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K940457 for LIPASE REAGENT SYSTEM, Substantially Equivalent on 1994-06-02. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Code CET
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1994-02-01
Decision date: 1994-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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