The following data is part of a premarket notification filed by Sita, Inc. with the FDA for Parainfluenza-i-cf Antigen And Control Antigen.
| Device ID | K872697 |
| 510k Number | K872697 |
| Device Name: | PARAINFLUENZA-I-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 |