The following data is part of a premarket notification filed by Sita, Inc. with the FDA for Respiratory Syncytial Virus Cf Antigen & Control.
Device ID | K872701 |
510k Number | K872701 |
Device Name: | RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL |
Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
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 | LKT |
CFR Regulation Number | 866.3480 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-07 |
Decision Date | 1987-09-18 |