The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Company with the FDA for Blood Bank Centrifuges For In Vitro Diagnostic Use.
Device ID | BK910022 |
510k Number | BK910022 |
Device Name: | Blood Bank Centrifuges For In Vitro Diagnostic Use |
Classification | Centrifuge, Blood-bank For In Vitro Diagnostic Use |
Applicant | E.I. DuPont De Nemours & Company medical Products Department Wilmington, DE 19898 |
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 | 1991-09-05 |
Decision Date | 1992-01-21 |