510(k) Premarket Notification

• Device Classification Name: drug mixture control materials
• 510(K) Number: K121143
• Models: 657, 657X, 659
• Device Name: LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
• Applicant: BIO-RAD LABORATORIES; 9500 jeronimo rd.; irvine, CA 92618 2017
• Contact: suzsnne parsons
• Regulation Number: 862.3280
• Classification Product Code: DIF
• Date Received: 04/16/2012
• Decision Date: 05/18/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Toxicology
• Review Advisory Committee: Clinical Chemistry
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No