The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Ena Jo-1 Kit (eia Method).
Device ID | K946124 |
510k Number | K946124 |
Device Name: | HEMAGEN ENA JO-1 KIT (EIA METHOD) |
Classification | Extractable Antinuclear Antibody, Antigen And Control |
Applicant | HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD. Waltlham, MA 02154 |
Contact | Joseph M Califano |
Correspondent | Joseph M Califano HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD. Waltlham, 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 | 1994-12-15 |
Decision Date | 1995-02-22 |