The following data is part of a premarket notification filed by Mp Biomedicals, Llc. with the FDA for Mp Rapidoxy Test Strip, Model 07rd-7073.
| Device ID | K051958 |
| 510k Number | K051958 |
| Device Name: | MP RAPIDOXY TEST STRIP, MODEL 07RD-7073 |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | MP BIOMEDICALS, LLC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin J Hellen |
| Correspondent | Robin J Hellen MP BIOMEDICALS, LLC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-19 |
| Decision Date | 2006-07-21 |
| Summary: | summary |