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 | K150162 |
510k Number | K150162 |
Device Name: | First Sign Drug Of Abuse Dip Card Test, First Sign Drug Of Abuse Cup Test |
Classification | Gas Chromatography, Methamphetamine |
Applicant | W.H.P.M., Inc. 5358 Irwindale Ave. Irwindale, CA 91706 |
Contact | John Wan |
Correspondent | John Wan W.H.P.M., Inc. 5358 Irwindale Avenue Irwindale, CA 91706 |
Product Code | LAF |
Subsequent Product Code | DJG |
Subsequent Product Code | JXM |
CFR Regulation Number | 862.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-26 |
Decision Date | 2015-02-26 |
Summary: | summary |