The following data is part of a premarket notification filed by Bbi Diagnostics, A Seracare Company with the FDA for Quality Control Kits For Bloodborne Pathogen Testing Of Donors.
| Device ID | BK990032 |
| 510k Number | BK990032 |
| Device Name: | Quality Control Kits For Bloodborne Pathogen Testing Of Donors |
| Classification | Kit, Test (donors), For Bloodborne Pathogen |
| Applicant | BBI Diagnostics, A SeraCare Company 375 West Street West Bridgewater, MA 02379 |
| Product Code | MYZ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-22 |
| Decision Date | 2000-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816784020260 | BK990032 | 0 |
| 00816784020253 | BK990032 | 0 |