The following data is part of a premarket notification filed by Zymetx, Inc. with the FDA for Virastat Fitc-labeled Anti-influenza A And B Monoclonal Antibodies.
| Device ID | K984596 |
| 510k Number | K984596 |
| Device Name: | VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES |
| Classification | Antisera, Neutralization, Influenza Virus A, B, C |
| Applicant | ZYMETX, INC. 800 RESEARCH PKWY., SUITE 100 Oklahoma City, OK 73104 |
| Contact | Craig D Shimasaki |
| Correspondent | Craig D Shimasaki ZYMETX, INC. 800 RESEARCH PKWY., SUITE 100 Oklahoma City, OK 73104 |
| Product Code | GNR |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-28 |
| Decision Date | 1999-03-04 |
| Summary: | summary |