The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa3,doa, Coc/thc/opi2000 Doa3; Biosign Doa3, Coc/thc/opi2000; Status Ds Coc/thc/opi2000.
| Device ID | K992422 |
| 510k Number | K992422 |
| Device Name: | ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-21 |
| Decision Date | 1999-08-10 |