The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa2, Doa, Bar/bzo, Biosign Doa2, Bar/bzo, Status Ds Bar/bzo, Syva Rapidtest D.a.u. 2 Bar/bzo.
| Device ID | K991082 |
| 510k Number | K991082 |
| Device Name: | ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO |
| 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 |