SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS— 510(k) K960485

Name: FDA 510(k) clearance K960485
Creator: U.S. Food and Drug Administration
Published: 1996-05-10

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K960485 for SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS, Substantially Equivalent on 1996-05-10. Applicant: Beckman Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code JMO
Device class: Class 1
Regulation: 21 CFR 862.1415
Advisory panel: Clinical Chemistry
Date received: 1996-02-02
Decision date: 1996-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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