The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Chagas' Kit (eia Method).
| Device ID | K930272 |
| 510k Number | K930272 |
| Device Name: | HEMAGEN CHAGAS' KIT (EIA METHOD) |
| Classification | Enzyme Linked Immunosorbent Assay, T. Cruzi |
| 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 | MIU |
| CFR Regulation Number | 866.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-19 |
| Decision Date | 1995-05-19 |