The following data is part of a premarket notification filed by W.h.p.m., Inc. with the FDA for First Sign Multi-drug Dip Card Test, First Sign Multi-drug Cup Test, First Sign Drug Of Abuse Dip Card Test Marijuana, First Sign Drug Of Abuse Cup Test Marijuana.
Device ID | K171695 |
510k Number | K171695 |
Device Name: | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug Of Abuse Dip Card Test Marijuana, First Sign Drug Of Abuse Cup Test Marijuana |
Classification | Test, Amphetamine, Over The Counter |
Applicant | W.H.P.M., Inc. 5358 Irwindale Ave. Irwindale, CA 91706 |
Contact | John Wan |
Correspondent | Joe Shia LSI Consulting 504E Diamond Ave., Suite I Gaithersburg, MD 20877 |
Product Code | NFT |
Subsequent Product Code | LDJ |
Subsequent Product Code | NFY |
Subsequent Product Code | NGG |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-07 |
Decision Date | 2018-02-05 |
Summary: | summary |