IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT— 510(k) K974564

Name: FDA 510(k) clearance K974564
Creator: U.S. Food and Drug Administration
Published: 1998-02-17

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K974564 for IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT, Substantially Equivalent on 1998-02-17. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code DEB
Device class: Class 2
Regulation: 21 CFR 866.5620
Advisory panel: Immunology
Date received: 1997-12-05
Decision date: 1998-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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