The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Abusign Doa 3, Doa, Coc/thc/opi, Accusign Doa 3, Biosign Doa 3, Coc/thc/oopi.
| Device ID | K954571 |
| 510k Number | K954571 |
| Device Name: | ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI |
| 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 |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1995-11-03 |