The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Ena [rnp/sm] Kit (eia Method).
Device ID | K915272 |
510k Number | K915272 |
Device Name: | HEMAGEN ENA [RNP/SM] KIT (EIA METHOD) |
Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
Applicant | HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
Contact | Charles A.willard |
Correspondent | Charles A.willard HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
Product Code | LJM |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-25 |
Decision Date | 1992-03-17 |