AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200— 510(k) K882475

Name: FDA 510(k) clearance K882475
Creator: U.S. Food and Drug Administration
Published: 1988-10-06

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K882475 for AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200, Substantially Equivalent on 1988-10-06. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1988-06-15
Decision date: 1988-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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