IMMUNOCARD STAT! RSV MODEL #750630
FDA 510(k) clearance K041445 · decided 2004-08-13
Clearance details
- K-number
- K041445
- Device name
- IMMUNOCARD STAT! RSV MODEL #750630
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-01
- Decision date
- 2004-08-13
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- GQG
- Device class
- 1
- Regulation number
- 866.3480
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, 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 |
|---|---|---|
| Clungene RSV Antigen Rapid Test (K253318) | Hangzhou Clongene Biotech Co., Ltd. | 2026-01-30 |
| Nano-Check™ RSV Test (K240280) | Nano-Ditech Corporation | 2024-07-30 |
| Sofia RSV FIA on Sofia 2 analyzer (K162911) | Quidel Corporation | 2017-02-22 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV (K133140) | Becton, Dickinson & CO | 2013-11-15 |
| BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV (K132456) | Becton, Dickinson and Company | 2013-11-07 |
| SOFIA(R) RSV FIA (K130398) | Quidel Corp. | 2013-08-13 |
| BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV (K121633) | Becton, Dickinson and Company | 2012-09-18 |
| QUICKVUE RSV 10 (K101918) | Quidel Corp. | 2010-09-24 |
| BD DIRECTIGEN EZ RSV (K101514) | Becton, Dickinson & CO | 2010-07-09 |
| RAMP RSV ASSAY (K091235) | Response Biomedical Corp. | 2009-07-24 |
| QUICK VUE RSV TEST, MODELS 20193, 20199 (K070747) | Quidel Corp. | 2007-04-23 |
| BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 (K032166) | Binax, Inc. | 2003-10-21 |
Recalls involving this device
No recalls on record reference this clearance.