The following data is part of a premarket notification filed by Zymetx, Inc. with the FDA for Zstatflu Test For Influenza Types A And B Viruses.
| Device ID | K982429 |
| 510k Number | K982429 |
| Device Name: | ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| 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 | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1998-08-25 |
| Summary: | summary |