The following data is part of a premarket notification filed by Sita, Inc. with the FDA for Adenovirus Cf Antigen And Control Antigen.
Device ID | K872698 |
510k Number | K872698 |
Device Name: | ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGEN |
Classification | Antisera, Cf, Adenovirus 1-33 |
Applicant | SITA, INC. REGULATORY AFFAIRS DEPARTMENT 130 SO. MAIN STREET Allentown, NJ 08501 |
Contact | Janis F Charlton |
Correspondent | Janis F Charlton SITA, INC. REGULATORY AFFAIRS DEPARTMENT 130 SO. MAIN STREET Allentown, NJ 08501 |
Product Code | GOA |
CFR Regulation Number | 866.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-07 |
Decision Date | 1987-09-18 |