510(k) K023779
- Device
- RSV OIA
- Applicant
- THERMO BIOSTAR, INC.
- 510(k) number
- K023779
- Product code
- GQG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-14
- Date received
- 2002-11-12
- Regulation
- 866.3480
- Classification name
- Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN G ADAMS
- Address
- 331 S. 104th St. Louisville CO US 80027 80027
FDA Registration Numbers#
- 3005174594
- 2030538
- 3011287770
- 3013557562
- 3033507883
- 3009238284
- 3014150341
- 8010096
- 3012187635
- 3007886372
- 1645225
- 9615056
- 1924669
- 2032682
- 2029372
- 3006948883
- 3008517993
- 3029906631
- 3004205692
- 3031590640
- 3009414546
- 2022994
- 3033751096
- 3012494290
- 3034246205
- 3013296716
- 3003750284
- 1119779
- 1221359
- 3003917514
- 3002792284
- 3017662853
- 3021090658
- 2024674
- 3043196750
Source Documents#
Other 510(k) Records For Product Code GQG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253318 | Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. | 2026-01-30 |
| K240280 | Nano-Check™ RSV Test | Nano-Ditech Corporation | 2024-07-30 |
| K162911 | Sofia RSV FIA on Sofia 2 analyzer | Quidel Corporation | 2017-02-22 |
| K133140 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV | Becton, Dickinson & CO | 2013-11-15 |
| K132456 | BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV | Becton, Dickinson and Company | 2013-11-07 |
| K130398 | SOFIA(R) RSV FIA | Quidel Corp. | 2013-08-13 |
| K121633 | BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV | Becton, Dickinson and Company | 2012-09-18 |
| K101918 | QUICKVUE RSV 10 | Quidel Corp. | 2010-09-24 |
| K101514 | BD DIRECTIGEN EZ RSV | Becton, Dickinson & CO | 2010-07-09 |
| K091235 | RAMP RSV ASSAY | Response Biomedical Corp. | 2009-07-24 |
| K070747 | QUICK VUE RSV TEST, MODELS 20193, 20199 | Quidel Corp. | 2007-04-23 |
| K041445 | IMMUNOCARD STAT! RSV MODEL #750630 | Meridian Bioscience, Inc. | 2004-08-13 |
| K032166 | BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 | Binax, Inc. | 2003-10-21 |
| K022845 | SAS RSV TEST | Sa Scientific, Inc. | 2003-01-29 |
| K022133 | BD DIRECTIGEN EZ RSV KIT | Becton, Dickinson & CO | 2002-12-10 |
Legacy Summary#
summary
FDA Review#
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