The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Bio Check Whole Blood/plasma/sermon Model #801116.
| Device ID | K041619 |
| 510k Number | K041619 |
| Device Name: | BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin J Hellen, M.s. |
| Correspondent | Robin J Hellen, M.s. BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-15 |
| Decision Date | 2004-12-17 |
| Summary: | summary |