The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Lifesign Dxpress, Model Lsr2000.
| Device ID | K050955 |
| 510k Number | K050955 |
| Device Name: | LIFESIGN DXPRESS, MODEL LSR2000 |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-15 |
| Decision Date | 2006-01-23 |
| Summary: | summary |