The following data is part of a premarket notification filed by Access Bio, Inc. with the FDA for Carestart Flu A&b Plus.
| Device ID | K191514 |
| 510k Number | K191514 |
| Device Name: | CareStart Flu A&B Plus |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | Access Bio, Inc. 65 Clyde Road, Suite A. Somerset, NJ 08873 |
| Contact | Sang Joon Han |
| Correspondent | Jongrak Kim Access Bio, Inc. 65 Clyde Road, Suite A. Somerset, NJ 08873 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-07 |
| Decision Date | 2020-02-18 |