The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Cardiac Markers Control Lt.
| Device ID | K980556 |
| 510k Number | K980556 |
| Device Name: | LIQUICHEK CARDIAC MARKERS CONTROL LT |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-13 |
| Decision Date | 1998-02-25 |
| Summary: | summary |