The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Mop, Biosign Mop, Staus Ds Mop.
| Device ID | K981771 |
| 510k Number | K981771 |
| Device Name: | ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 -7139 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 -7139 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-19 |
| Decision Date | 1998-06-12 |