The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Ena (ss-a/ss-b) Kit (eia Method).
| Device ID | K915234 |
| 510k Number | K915234 |
| Device Name: | HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
| Contact | Charles Q Willand |
| Correspondent | Charles Q Willand HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, 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 | 1991-11-22 |
| Decision Date | 1991-12-20 |