The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa 3/doa 3 (bzo/bar/pcp), Bzo/bar/pcp, Biosign Doa 3/bzo/bar/pcp, Biosign Bzo/bar/pcp.
| Device ID | K961325 |
| 510k Number | K961325 |
| Device Name: | ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. ROUTE 1 P.O. BOX 7139 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. 4242 U.S. ROUTE 1 P.O. BOX 7139 Monmouth Junction, NJ 08852 -1905 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-06-12 |