510(k) K971494
- Device
- VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
- Applicant
- ZYMETX, INC.
- 510(k) number
- K971494
- Product code
- GNX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-09-10
- Date received
- 1997-04-24
- Regulation
- 866.3330
- Classification name
- Antigens, Cf (including Cf Control), Influenza Virus A, B, C
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CRAIG D SHIMASAKI
- Address
- 800 Research Pkwy., Suite 100 Oklahoma City OK US 73104 73104
FDA Registration Numbers#
- 3003750284
- 2030538
- 3033507883
- 9615056
- 3002792284
- 3014150341
- 8010096
- 3023228837
- 3043226252
- 3012494290
- 3013530901
- 3026664926
Source Documents#
Other 510(k) Records For Product Code GNX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133411 | ALERE BINAXNOW INFLUENZA A & B CARD | Alere Scarborough, Inc D/B/A Binax, Inc. | 2013-12-05 |
| K132352 | SAS FLUALERT A & B, SAS INFLUENZA A TEST | Sa Scientific , Ltd. | 2013-08-22 |
| K131804 | REMEL XPECT FLU A&B | Remel, Inc. | 2013-07-12 |
| K131599 | QUICK VUE INFLUENZA | Quidel Corporation | 2013-07-05 |
| K131606 | SOFIA INFLUENZA A+B FIA | Quidel Corp. | 2013-07-05 |
| K131619 | QUICKVUE INFLUENZA A+B | Quidel Corp. | 2013-06-28 |
| K123182 | OSOM INFLUENZA A&B TEST MODEL 190 | SEKISUI Diagnostics, LLC | 2012-11-05 |
| K924006 | BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1992-12-29 |
| K901493 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B | Whittaker Bioproducts, Inc. | 1990-06-27 |
| K893579 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A | Whittaker Bioproducts, Inc. | 1990-01-16 |
| K884191 | INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION | Baxter Diagnostics, Inc. | 1988-11-22 |
| K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI | Boots-Celltech Diagnostics, Inc. | 1988-02-24 |
| K871231 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| K871233 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| K843659 | INFLUENZA A2 VIRUS | Institute Virion , Ltd. | 1985-09-26 |
Legacy Summary#
summary
FDA Review#
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