The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Abusign(tm) Opi, Doa-opi, Accusign(tm) Opi, Doa-opi, Biosign(tm) Opi, Doa-opi.
| Device ID | K945608 |
| 510k Number | K945608 |
| Device Name: | ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-15 |
| Decision Date | 1995-02-10 |