510(k) K191514
- Device
- CareStart Flu A&B Plus
- Applicant
- Access Bio, Inc.
- 510(k) number
- K191514
- Product code
- PSZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-02-18
- Date received
- 2019-06-07
- Regulation
- 866.3328
- Classification name
- Devices Detecting Influenza A, B, And C Virus Antigens
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Dual Track
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sang Joon Han
- Address
- 65 Clyde Rd., Suite A. Somerset NJ US 08873 08873
FDA Registration Numbers#
- 3013332582
- 3010381606
- 3005174594
- 2030538
- 3013557562
- 3033507883
- 3026565854
- 1524213
- 1649661
- 3007886372
- 1645225
- 1924669
- 2029372
- 3014684020
- 3005586126
- 2435505
- 3026664926
- 3010082909
- 3006948883
- 3029906631
- 3017772438
- 3005984081
- 3033751096
- 3024753119
- 2246703
- 3012494290
- 3003750284
- 1119779
- 1221359
- 3003917514
- 3002792284
- 3017662853
- 2431980
- 3021090658
- 2024674
- 3043196750
Source Documents#
Other 510(k) Records For Product Code PSZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | 2026-01-15 |
| K250398 | Innovita Flu A/B Antigen Rapid Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2025-07-03 |
| K241188 | Acucy® Influenza A&B Test with the Acucy® 2 System | SEKISUI Diagnostics, LLC | 2025-04-18 |
| K232434 | BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit | Bd | 2023-12-05 |
| K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit | Bd | 2023-01-27 |
| K192719 | Osom Ultra Plus Flu A&B Test Kit | SEKISUI Diagnostics, LLC | 2020-04-03 |
| K182001 | Acucy Influenza A&B Test with the Acucy System | SEKISUI Diagnostics, LLC | 2018-12-17 |
| K182157 | BioSign Flu A+B | Princeton BioMeditech Corp. | 2018-09-18 |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | Alere Scarborough, Inc. | 2018-08-08 |
| K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | Bd | 2018-03-20 |
| K180288 | QuickVue Influenza A+B | Quidel Corporation | 2018-02-13 |
| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | Alere Scarborough, Inc. | 2017-12-13 |
| K162438 | Sofia Influenza A+B FIA on Sofia 2 | Quidel Corporation | 2017-04-14 |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | Alere Scarborough, Inc. | 2017-04-10 |
| K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory Kit | Becton, Dickinson & CO | 2016-02-25 |
Legacy Summary#
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FDA Review#
Decision Summary