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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Opiates, Over The Counter
510(k) Number K240295
Device Name InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)
Applicant
Instanosis Inc
1004 w 9th Avenue
Suite 10
King of Prussia,  PA  19406
Applicant Contact Xiaofeng Xia
Correspondent
LSI International Inc
504E Diamond Ave., Suite H
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
NGL  
Date Received02/01/2024
Decision Date 03/28/2024
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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