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, First Sign Drug Of Abuse Cup Test.
| Device ID | K151441 |
| 510k Number | K151441 |
| Device Name: | First Sign Drug Of Abuse Dip Card Test, First Sign Drug Of Abuse Cup Test |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | W.H.P.M., INC. 5358 IRWINDALE AVE. Irwindale, CA 91706 |
| Contact | John Wan |
| Correspondent | Joe Shia LSI INTERNATIONAL 504 E DIAMOND AVE., SUITE I Gaithersburg, MD 20877 |
| Product Code | DJR |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LCM |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-29 |
| Decision Date | 2015-06-29 |
| Summary: | summary |