The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Hemagen Rheumatoid Factor Kit (eia Method).
Device ID | K962836 |
510k Number | K962836 |
Device Name: | HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) |
Classification | System, Test, Rheumatoid Factor |
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 | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-22 |
Decision Date | 1996-09-12 |
Summary: | summary |