The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Abusign Doa 2, Doa, Coc/thc, Doa2, Biosign Doa2, Coc/thc.
| Device ID | K952361 |
| 510k Number | K952361 |
| Device Name: | ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC |
| 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 |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1995-10-26 |