The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biosign Flu A + B, Status Flu A & B.
| Device ID | K132465 |
| 510k Number | K132465 |
| Device Name: | BIOSIGN FLU A + B, STATUS 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, Ph.d. |
| Correspondent | Kyung-ah Kim, Ph.d. 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-07 |
| Decision Date | 2013-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855574005407 | K132465 | 000 |
| 00816917022925 | K132465 | 000 |