IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT— 510(k) K973813

Name: FDA 510(k) clearance K973813
Creator: U.S. Food and Drug Administration
Published: 1997-11-20

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K973813 for IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT, Substantially Equivalent on 1997-11-20. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code JZG
Device class: Class 2
Regulation: 21 CFR 866.5630
Advisory panel: Immunology
Date received: 1997-10-07
Decision date: 1997-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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