The following data is part of a premarket notification filed by Mp Biomedicals, Llc with the FDA for Mp Doa-10 Panel Test Cup, Mp Doa-11 Panel Test Cup.
| Device ID | K162395 |
| 510k Number | K162395 |
| Device Name: | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | MP BIOMEDICALS, LLC 1429 ROLLINS ROAD Burlingame, CA 94010 |
| Contact | Star Han |
| Correspondent | Sean Gemmill MP BIOMEDICALS, LLC 3 HUTTON CENTRE DR. 100 Santa Ana, CA 92707 |
| Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-26 |
| Decision Date | 2017-06-02 |
| Summary: | summary |