The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Blood Irradiator.
| Device ID | BK890028 |
| 510k Number | BK890028 |
| Device Name: | Blood Irradiator |
| Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
| Applicant | Hemagen Diagnostics, Inc. 9033 Red Branch Road Columbia, MD 21045 |
| Product Code | MZB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-17 |
| Decision Date | 1989-12-11 |