The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Ena Screening Kit (eia Method).
Device ID | K915058 |
510k Number | K915058 |
Device Name: | HEMAGEN ENA SCREENING KIT (EIA METHOD) |
Classification | Extractable Antinuclear Antibody, Antigen And Control |
Applicant | HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
Contact | A Willand |
Correspondent | A 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 | 1991-11-08 |
Decision Date | 1991-12-20 |