ALERE BINAXNOW INFLUENZA A & B CARD
FDA 510(k) clearance K133411 · decided 2013-12-05
Clearance details
- K-number
- K133411
- Device name
- ALERE BINAXNOW INFLUENZA A & B CARD
- Applicant
- Alere Scarborough, Inc D/B/A Binax, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-07
- Decision date
- 2013-12-05
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- GNX
- Device class
- 1
- Regulation number
- 866.3330
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Scarborough, ME, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SAS FLUALERT A & B, SAS INFLUENZA A TEST (K132352) | Sa Scientific , Ltd. | 2013-08-22 |
| REMEL XPECT FLU A&B (K131804) | Remel, Inc. | 2013-07-12 |
| QUICK VUE INFLUENZA (K131599) | Quidel Corporation | 2013-07-05 |
| SOFIA INFLUENZA A+B FIA (K131606) | Quidel Corp. | 2013-07-05 |
| QUICKVUE INFLUENZA A+B (K131619) | Quidel Corp. | 2013-06-28 |
| OSOM INFLUENZA A&B TEST MODEL 190 (K123182) | SEKISUI Diagnostics, LLC | 2012-11-05 |
| VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (K971494) | Zymetx, Inc. | 1997-09-10 |
| BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY (K924006) | Baxter Healthcare Corp | 1992-12-29 |
| FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (K901493) | Whittaker Bioproducts, Inc. | 1990-06-27 |
| FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (K893579) | Whittaker Bioproducts, Inc. | 1990-01-16 |
| INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION (K884191) | Baxter Diagnostics, Inc. | 1988-11-22 |
| IMAGEN INFLUENZA VIRUS A AND B TESTMI (K872958) | Boots-Celltech Diagnostics, Inc. | 1988-02-24 |
Recalls involving this device
No recalls on record reference this clearance.