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 | BK010038 |
510k Number | BK010038 |
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 | 2001-09-19 |
Decision Date | 2001-12-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816784020222 | BK010038 | 0 |
00816784020215 | BK010038 | 0 |