The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc with the FDA for Quality Control Kits For Blood Banking Reagents.
Device ID | BK960070 |
510k Number | BK960070 |
Device Name: | Quality Control Kits For Blood Banking Reagents |
Classification | Kit, Quality Control For Blood Banking Reagents |
Applicant | Fujirebio Diagnostics, Inc 201 Great Valley Parkway Malvern, PA 19355 |
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 | 1996-09-05 |
Decision Date | 1997-06-19 |