The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Cardiac Markers Control Lt Level 1,2,3, Models 646,647,648.
| Device ID | K012656 |
| 510k Number | K012656 |
| Device Name: | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos 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 | 2001-08-13 |
| Decision Date | 2001-09-06 |
| Summary: | summary |