The following data is part of a premarket notification filed by Zymetx, Inc. with the FDA for Virazyme Culture Confirmation Screen For Influenza And Parainfluenza Viruses.
| Device ID | K950838 |
| 510k Number | K950838 |
| Device Name: | VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES |
| Classification | Antigens, Ha (including Ha Control), Influenza Virus A, B, C |
| Applicant | ZYMETX, INC. 25 NORTHWEST 4TH ST. Oklahoma City, OK 73102 |
| Contact | Craig D Shimasaki |
| Correspondent | Craig D Shimasaki ZYMETX, INC. 25 NORTHWEST 4TH ST. Oklahoma City, OK 73102 |
| Product Code | GNT |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-24 |
| Decision Date | 1996-06-17 |
| Summary: | summary |