LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)

Drug Mixture Control Materials

Bio-Rad Laboratories

The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Whole Blood Immunosuppressant Control Tilevel (1,2 And 3).

Pre-market Notification Details

• Device ID: K121143
• 510k Number: K121143
• Device Name: LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
• Classification: Drug Mixture Control Materials
• Applicant: Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017
• Contact: Suzsnne Parsons
• Correspondent: Suzsnne Parsons; Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017
• Product Code: DIF
• CFR Regulation Number: 862.3280 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-16
• Decision Date: 2012-05-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847661005827	K121143	000
00847661005810	K121143	000
00847661005803	K121143	000
00847661005797	K121143	000
00847661005766	K121143	000