The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Ena [jo-i] Kit.
| Device ID | K902139 |
| 510k Number | K902139 |
| Device Name: | HEMAGEN ENA [JO-I] KIT |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
| Contact | Charles A Willand |
| Correspondent | Charles A Willand HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-09 |
| Decision Date | 1990-05-18 |