The following data is part of a premarket notification filed by Bbi Diagnostics, A Seracare Company with the FDA for Quality Control Kits For Blood Banking Reagents.
| Device ID | BK970004 |
| 510k Number | BK970004 |
| Device Name: | Quality Control Kits For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | BBI Diagnostics, A SeraCare Company 375 West Street West Bridgewater, MA 02379 |
| Product Code | KSF |
| CFR Regulation Number | 864.9650 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1999-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816784020475 | BK970004 | 0 |
| 00816784020468 | BK970004 | 0 |
| 00816784020451 | BK970004 | 0 |