510(k) Premarket Notification

• Device Classification Name: multiplex flow immunoassay, t.gondii, rubella and cmv.
• 510(K) Number: K120572
• Device Name: BIOPLEX 2200 TORC IGG
• Applicant: BIO-RAD LABORATORIES, INC.; 5500 east 2nd st.; benicia, CA 94510
• Contact: juang wang
• Regulation Number: 866.3510
• Classification Product Code: OMI
• Subsequent Product Codes: JIX JJY
• Date Received: 02/27/2012
• Decision Date: 03/26/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Microbiology
• Review Advisory Committee: Microbiology
• summary: summary
• FDA Review: Decision Summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No