The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biosign Flu A+b.
| Device ID | K182157 |
| 510k Number | K182157 |
| Device Name: | BioSign Flu A+B |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | Princeton BioMeditech Corp. 4242 US Highway 1 Monmouth Junction, NJ 08852 |
| Contact | Kyung-ah Kim |
| Correspondent | Kyung-ah Kim Princeton BioMeditech Corp. 4242 US Highway 1 Monmouth Junction, NJ 08852 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-09 |
| Decision Date | 2018-09-18 |