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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 K200801
Device Name Quantisal Oral Fluid Collection Device
Applicant
Immunalysis Corporation
829 Towne Center Drive
Pomona,  CA  91767
Applicant Contact Wenying (Jessica) Zhu
Correspondent
Immunalysis Corporation
829 Towne Center Drive
Pomona,  CA  91767
Correspondent Contact Wenying (Jessica) Zhu
Regulation Number862.1675
Classification Product Code
PJD  
Date Received03/27/2020
Decision Date 07/28/2020
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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