The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status Ds Met.
| Device ID | K014192 |
| 510k Number | K014192 |
| Device Name: | LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET |
| Classification | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Product Code | MVO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-05-23 |
| Summary: | summary |