BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET


Device Classification Name

multiplex flow immunoassay, t.gondii, rubella and cmv.

510(k) Number K080008
Device Name BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
Applicant
BIO-RAD LABORATORIES, INC.
49 plain street
north attleboro, 
MA 
02760

Applicant Contact cynthia sinclair
Correspondent
BIO-RAD LABORATORIES, INC.
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact cynthia sinclair
Regulation Number 866.3510
Classification Product Code
OMI  
Subsequent Product Codes
JIX   JJY  
Date Received 01/02/2008
Decision Date 02/23/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No