The following data is part of a premarket notification filed by Symex Corp. with the FDA for Virastat(r) Fitc-label Anti-parainflu 1,2&3 Mono Ant.
| Device ID | K933575 |
| 510k Number | K933575 |
| Device Name: | VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT |
| Classification | Antisera, Neutralization, Parainfluenza Virus 1-4 |
| Applicant | SYMEX CORP. P.O. BOX 690355 Tulsa, OK 74169 |
| Contact | Craig D Shimasaki |
| Correspondent | Craig D Shimasaki SYMEX CORP. P.O. BOX 690355 Tulsa, OK 74169 |
| Product Code | GQP |
| CFR Regulation Number | 866.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-23 |
| Decision Date | 1994-11-28 |