SYNCHRON ENZYME VALIDATOR SET— 510(k) K951964

Name: FDA 510(k) clearance K951964
Creator: U.S. Food and Drug Administration
Published: 1995-06-29

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K951964 for SYNCHRON ENZYME VALIDATOR SET, Substantially Equivalent on 1995-06-29. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1995-04-27
Decision date: 1995-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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