The following data is part of a premarket notification filed by Lumiquick Diagnostics, Inc. with the FDA for Quickprofile Single Drug Of Abuse Device And Quick Profile Multi-drugs Of Abuse Screen Device.
| Device ID | K130213 |
| 510k Number | K130213 |
| Device Name: | QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | LUMIQUICK DIAGNOSTICS, INC. 27001 LA PAZ RD, STE 266B Mission Viejo, CA 92691 |
| Contact | Feng-yu Lee |
| Correspondent | Feng-yu Lee LUMIQUICK DIAGNOSTICS, INC. 27001 LA PAZ RD, STE 266B Mission Viejo, CA 92691 |
| Product Code | LDJ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-10-18 |
| Summary: | summary |