The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Immunology Control, Level 1,2,3, Trilevel Minipak.
| Device ID | K130761 |
| 510k Number | K130761 |
| Device Name: | LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne Parsons |
| Correspondent | Suzanne Parsons Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-20 |
| Decision Date | 2013-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661004554 | K130761 | 000 |
| 00847661004547 | K130761 | 000 |
| 00847661004530 | K130761 | 000 |
| 00847661004523 | K130761 | 000 |