BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET— 510(k) K080008

Name: FDA 510(k) clearance K080008
Creator: U.S. Food and Drug Administration
Published: 2009-02-23

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K080008 for BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET, Substantially Equivalent on 2009-02-23. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code OMI
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 2008-01-02
Decision date: 2009-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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