The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Cardiac Markers Control (cat. No. 685,686,687,688).
| Device ID | K961828 |
| 510k Number | K961828 |
| Device Name: | LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-13 |
| Decision Date | 1996-06-11 |
| Summary: | summary |