The following data is part of a premarket notification filed by Virion (u.s.), Inc. with the FDA for P.i.v. Complement-fixation (c.f.) Antigen.
| Device ID | K905385 |
| 510k Number | K905385 |
| Device Name: | P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN |
| Classification | Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 |
| Applicant | VIRION (U.S.), INC. 4 UPPERFIELD RD. Morristown, NJ 07960 |
| Contact | Hausler, Jr. |
| Correspondent | Hausler, Jr. VIRION (U.S.), INC. 4 UPPERFIELD RD. Morristown, NJ 07960 |
| Product Code | GQS |
| CFR Regulation Number | 866.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-30 |
| Decision Date | 1991-03-21 |