The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Lifesign(tm) 1, Biosign(tm) 1, Lifesign Plus(tm), Lifesign(tm) Hcg.
| Device ID | K945514 |
| 510k Number | K945514 |
| Device Name: | LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG |
| Classification | Kit, Test, Pregnancy, Hcg, 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-09 |
| Decision Date | 1995-02-10 |