The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck High Sensitivity C-reactive Protein Enzyme Immunoassay Test Kit, Model Bc-1119.
| Device ID | K003851 |
| 510k Number | K003851 |
| Device Name: | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| 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 | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-12 |
| Decision Date | 2001-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239039545 | K003851 | 000 |
| 00850392007190 | K003851 | 000 |
| 00083059070330 | K003851 | 000 |
| 08305900070330 | K003851 | 000 |
| 04048474039542 | K003851 | 000 |