The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Cardiac Troponins Control, Levels 1,2 And 3, Trilevel/minipak.
| Device ID | K140916 |
| 510k Number | K140916 |
| Device Name: | LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 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 | 2014-04-10 |
| Decision Date | 2014-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610520551707 | K140916 | 000 |
| 03610520551356 | K140916 | 000 |