The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Doa 3,accusign Doa, Accusign Bar/bzo/mtd, Biosign Doa 3, Biosign Bar/bzo/mtd.
| Device ID | K961010 |
| 510k Number | K961010 |
| Device Name: | ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-13 |
| Decision Date | 1996-06-28 |