The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Ena Screen-6 Kit (eia Method).
| Device ID | K952077 |
| 510k Number | K952077 |
| Device Name: | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD. Waltlham, MA 02154 |
| Contact | Joseph M Califano |
| Correspondent | Joseph M Califano HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD. Waltlham, MA 02154 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-03 |
| Decision Date | 1995-06-05 |