The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Lifesign Home Drug Test (ecstasy/met), Status Stik Met & Mdma, Accusign Stik Met & Mdma, Accustik Met & Mdma.
| Device ID | K023837 |
| 510k Number | K023837 |
| Device Name: | LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA |
| Classification | Gas Chromatography, Methamphetamine |
| 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 | LAF |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-18 |
| Decision Date | 2003-09-15 |
| Summary: | summary |