The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Febrile Antigen Kit.
Device ID | K822663 |
510k Number | K822663 |
Device Name: | FEBRILE ANTIGEN KIT |
Classification | Antigens (febrile), Agglutination, Brucella Spp. |
Applicant | OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GSO |
CFR Regulation Number | 866.3085 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-03 |
Decision Date | 1982-09-21 |