The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa 5 (thc/opi/coc/met Or Amp/pcp).
| Device ID | K962353 |
| 510k Number | K962353 |
| Device Name: | ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 -7139 |
| Contact | Jemo Kang, Ph.d. |
| Correspondent | Jemo Kang, Ph.d. PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 -7139 |
| Product Code | DIO |
| Subsequent Product Code | DNI |
| Subsequent Product Code | LCM |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-18 |
| Decision Date | 1996-08-19 |