The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Ferritin Elisa Model Bc-1025.
| Device ID | K992517 |
| 510k Number | K992517 |
| Device Name: | BIOCHECK FERRITIN ELISA MODEL BC-1025 |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin Hellen |
| Correspondent | Robin Hellen BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-28 |
| Decision Date | 1999-09-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013323 | K992517 | 000 |
| B24225FERHUE010 | K992517 | 000 |
| 00840239018724 | K992517 | 000 |
| 00850392007251 | K992517 | 000 |