The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Cardiac-1 Crp Rapid Test, Model Bc-804114.
| Device ID | K040030 |
| 510k Number | K040030 |
| Device Name: | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 |
| Classification | System, Test, C-reactive Protein |
| Applicant | BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin J Hellen |
| Correspondent | Robin J Hellen BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-07 |
| Decision Date | 2004-06-16 |
| Summary: | summary |