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

Test, Amphetamine, Over The Counter

W.H.P.M., Inc.

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.

Pre-market Notification Details

Device IDK171695
510k NumberK171695
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
ClassificationTest, Amphetamine, Over The Counter
Applicant W.H.P.M., Inc. 5358 Irwindale Ave. Irwindale,  CA  91706
ContactJohn Wan
CorrespondentJoe Shia
LSI Consulting 504E Diamond Ave., Suite I Gaithersburg,  MD  20877
Product CodeNFT  
Subsequent Product CodeLDJ
Subsequent Product CodeNFY
Subsequent Product CodeNGG
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-07
Decision Date2018-02-05
Summary:summary

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