The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquidchek Cardiac Markers Plus Control Lt; Level 1c, Level 2, Level 3, Trilevel Minipak.
| Device ID | K123663 |
| 510k Number | K123663 |
| Device Name: | LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 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 | 2012-11-28 |
| Decision Date | 2012-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661004165 | K123663 | 000 |
| 00847661004158 | K123663 | 000 |
| 00847661004141 | K123663 | 000 |
| 00847661004134 | K123663 | 000 |