ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY— 510(k) K031606

Name: FDA 510(k) clearance K031606
Creator: U.S. Food and Drug Administration
Published: 2003-06-20

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K031606 for ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY, Substantially Equivalent on 2003-06-20. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 2003-05-22
Decision date: 2003-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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