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 |