BIOPLEX 2200 EBV IGG AND SYPHILIS IGG— 510(k) K120439

Name: FDA 510(k) clearance K120439
Creator: U.S. Food and Drug Administration
Published: 2012-03-14

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K120439 for BIOPLEX 2200 EBV IGG AND SYPHILIS IGG, Substantially Equivalent on 2012-03-14. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2012-02-13
Decision date: 2012-03-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Benicia, CA, US

Download summary PDF View on FDA.gov ↗

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