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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Propoxyphene, Over The Counter
510(k) Number K210327
Device Name First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
Applicant
W.H.P.M., Inc.
5358 Irwindale Ave.
Irwindale,  CA  91706
Applicant Contact John Wan
Correspondent
Lsi Consulting
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3700
Classification Product Code
QBF  
Subsequent Product Codes
LCM   NFT   NFV   NFW   NFY  
NGG   NGL   PTG   PTH   QAW  
Date Received02/04/2021
Decision Date 08/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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