The following data is part of a premarket notification filed by Bbi Diagnostics, A Seracare Company with the FDA for Single (specified) Analyte Controls, (assayed And Unassayed).
| Device ID | BK040067 |
| 510k Number | BK040067 |
| Device Name: | Single (Specified) Analyte Controls, (Assayed And Unassayed) |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BBI Diagnostics, A SeraCare Company 375 West Street West Bridgewater, MA 02379 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-23 |
| Decision Date | 2004-11-19 |