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 |