The following data is part of a premarket notification filed by Zymetx, Inc. with the FDA for Virazyme Influenza Id Test For Influenza Types A And B Viruses.
| Device ID | K971494 |
| 510k Number | K971494 |
| Device Name: | VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES |
| Classification | Antigens, Cf (including Cf Control), 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 | GNX |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-24 |
| Decision Date | 1997-09-10 |
| Summary: | summary |