The following data is part of a premarket notification filed by Jouan, Inc. with the FDA for Blood Bank Centrifuges For In Vitro Diagnostic Use.
| Device ID | BK860037 |
| 510k Number | BK860037 |
| Device Name: | Blood Bank Centrifuges For In Vitro Diagnostic Use |
| Classification | Centrifuge, Blood-bank For In Vitro Diagnostic Use |
| Applicant | Jouan, Inc. route 8,box 1202;p.o. Box 2716 Winchester, VA 22601 |
| Product Code | KSO |
| CFR Regulation Number | 864.9275 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-29 |
| Decision Date | 1986-12-15 |