ENZYGNOST LIPASE TEST— 510(k) K844240

Name: FDA 510(k) clearance K844240
Creator: U.S. Food and Drug Administration
Published: 1985-02-12

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K844240 for ENZYGNOST LIPASE TEST, Substantially Equivalent on 1985-02-12. Applicant: Behring Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code CET
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1984-11-01
Decision date: 1985-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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