The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Abusign(tm) Doa 4, Doa, Thc/opi/coc/amp Or Met, Biosign(tm) Doa 4, Thc/opi/coc/amp Or Met.
| Device ID | K945549 |
| 510k Number | K945549 |
| Device Name: | ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 |
| Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-10-26 |