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 |