IMX RUBELLA IGM ANTIBODY ASSAY— 510(k) K931059

Name: FDA 510(k) clearance K931059
Creator: U.S. Food and Drug Administration
Published: 1994-12-19

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K931059 for IMX RUBELLA IGM ANTIBODY ASSAY, Substantially Equivalent on 1994-12-19. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1993-03-01
Decision date: 1994-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.