The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Lifesign Doa 4 (thc/opi/coc/met).
| Device ID | K014193 |
| 510k Number | K014193 |
| Device Name: | LIFESIGN DOA 4 (THC/OPI/COC/MET) |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | MVO |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-05-23 |
| Summary: | summary |