The following data is part of a premarket notification filed by Virion (u.s.), Inc. with the FDA for Coxsackie Virus B1-b6 Cf Antigens.
| Device ID | K921618 |
| 510k Number | K921618 |
| Device Name: | COXSACKIE VIRUS B1-B6 CF ANTIGENS |
| Classification | Antigens, Cf (including Cf Control), Coxsackievirus A 1-24, B 1-6 |
| Applicant | VIRION (U.S.), INC. 4 UPPERFIELD RD. Morristown, NJ 07960 |
| Contact | William J Hausler |
| Correspondent | William J Hausler VIRION (U.S.), INC. 4 UPPERFIELD RD. Morristown, NJ 07960 |
| Product Code | GNG |
| CFR Regulation Number | 866.3145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1992-06-29 |