The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Seratest Rf (hemagglutination) Kit.
| Device ID | K855221 |
| 510k Number | K855221 |
| Device Name: | SERATEST RF (HEMAGGLUTINATION) KIT |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, MA 02154 |
| Contact | Charles A Willand |
| Correspondent | Charles A Willand HEMAGEN DIAGNOSTICS, INC. 34 BEAR HILL RD. Waltham, 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 | 1985-12-30 |
| Decision Date | 1986-04-22 |