The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Lifesign Coc, Status Stik Coc, Accusign Stik Coc, Accustik Coc.
| Device ID | K014069 |
| 510k Number | K014069 |
| Device Name: | LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-10 |
| Decision Date | 2002-06-10 |
| Summary: | summary |