The following data is part of a premarket notification filed by Dominion Biologicals Limited with the FDA for Kit, Quality Control For Blood Banking Reagents.
| Device ID | BK980009 |
| 510k Number | BK980009 |
| Device Name: | Kit, Quality Control For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | Dominion Biologicals Limited 5 Isnor Drive Dartmouth, Nova Scotia, B3B1M1, CANADA |
| 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 | 1998-04-08 |
| Decision Date | 1998-10-30 |