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 |