The following data is part of a premarket notification filed by Accugenics, Inc. with the FDA for Kit, Quality Control For Blood Banking Reagents.
| Device ID | BK810599 |
| 510k Number | BK810599 |
| Device Name: | Kit, Quality Control For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | Accugenics, Inc. Costa Mesa, CA 92626 |
| 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 | 1981-03-06 |
| Decision Date | 1981-03-31 |