The following data is part of a premarket notification filed by Institute Virion Ltd. with the FDA for Parainfluenza 1.
| Device ID | K843665 |
| 510k Number | K843665 |
| Device Name: | PARAINFLUENZA 1 |
| Classification | Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 |
| Applicant | INSTITUTE VIRION LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GQS |
| CFR Regulation Number | 866.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-17 |
| Decision Date | 1985-09-26 |