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 |