The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa3, Doa3(bzo/bar/pcp), Bzo/bar/pcp, Biosign Doa3, Doa3(bzo/bar/pcp), Bzo/bar/pcp.
| Device ID | K991076 |
| 510k Number | K991076 |
| Device Name: | ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-26 |
| Decision Date | 1999-04-15 |