DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
FDA 510(k) clearance K882629 · decided 1988-10-31
Clearance details
- K-number
- K882629
- Device name
- DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1988-06-27
- Decision date
- 1988-10-31
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- GQG
- Device class
- 1
- Regulation number
- 866.3480
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bd Becton Dickinson Vacutainer Systems Preanalytic
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| IMMUNOCARD STAT! RSV MODEL #750630 (K041445) | Meridian Bioscience, Inc. | 2004-08-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |