The following data is part of a premarket notification filed by Fujirebio, Inc. with the FDA for Quality Control Kits For Blood Banking Reagents.
| Device ID | BK940047 |
| 510k Number | BK940047 |
| Device Name: | Quality Control Kits For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | Fujirebio, Inc. 1129 Bloomfield Ave, West Caldwell, NJ 07006 |
| 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 | 1994-07-18 |
| Decision Date | 1995-11-29 |