The following data is part of a premarket notification filed by W.h.p.m., Inc. with the FDA for First Sign Drug Of Abuse Dip Card Test (mdma, Eddp, Nortriptyline), First Sign Drug Of Abuse Cup Test (mdma, Eddp, Nortriptyline).
| Device ID | K160793 |
| 510k Number | K160793 |
| Device Name: | First Sign Drug Of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug Of Abuse Cup Test (MDMA, EDDP, Nortriptyline) |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | W.H.P.M., INC. 5358 IRWINDALE AVE. Irwindale, CA 91706 |
| Contact | John Wan |
| Correspondent | Joe Shia LSI Consulting 504 East Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | DJR |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-23 |
| Decision Date | 2016-08-17 |
| Summary: | summary |