The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Status Ds Oxy.
| Device ID | K130650 |
| 510k Number | K130650 |
| Device Name: | STATUS DS OXY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. HIGHWAY 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Kyung-ah Kim |
| Correspondent | Kyung-ah Kim PRINCETON BIOMEDITECH CORP. 4242 U.S. HIGHWAY 1 Monmouth Junction, NJ 08852 -1905 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-11 |
| Decision Date | 2014-02-26 |
| Summary: | summary |