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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
510(k) Number K223781
Device Name Quantisal™ II Oral Fluid Collection Device
Applicant
Immunalysis Corporation
829 Towne Center Dr.
Pomona,  CA  91767
Applicant Contact Shubhajit Mitra
Correspondent
Immunalysis Corporation
829 Towne Center Dr.
Pomona,  CA  91767
Correspondent Contact Shubhajit Mitra
Regulation Number862.1675
Classification Product Code
PJD  
Date Received12/16/2022
Decision Date 07/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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