The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Cardiac Markers Plus Control Lt.
| Device ID | K150300 |
| 510k Number | K150300 |
| Device Name: | Liquichek Cardiac Markers Plus Control LT |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Suzanne Parsons Bio-Rad Laboratories 9500 Jeronimo Road 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 | 2015-02-06 |
| Decision Date | 2015-12-11 |
| Summary: | summary |