The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Parainfluenza 1,2, & 3 Antigens & Contr.
| Device ID | K802935 |
| 510k Number | K802935 |
| Device Name: | PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR |
| Classification | Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 |
| Applicant | ORION DIAGNOSTICA, INC. 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 | 1980-11-19 |
| Decision Date | 1980-12-31 |