The following data is part of a premarket notification filed by Sita, Inc. with the FDA for Parainfluenza-2-cf Antigen And Control Antigen.
Device ID | K872695 |
510k Number | K872695 |
Device Name: | PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN |
Classification | Antisera, Cf, Parainfluenza Virus 1-4 |
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 | GQT |
CFR Regulation Number | 866.3400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-07 |
Decision Date | 1987-09-18 |