The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biosign Flu A+b.
| Device ID | K083746 |
| 510k Number | K083746 |
| Device Name: | BIOSIGN FLU A+B |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Kyung-ah Kim |
| Correspondent | Kyung-ah Kim PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-17 |
| Decision Date | 2010-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608337000047 | K083746 | 000 |
| 20608337000065 | K083746 | 000 |
| 00840733101656 | K083746 | 000 |
| 00840733101649 | K083746 | 000 |