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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name kit, test, pregnancy, hcg, over the counter
510(k) Number K232715
Device Name Distinct® Digital Pregnancy Test
ACON Laboratories, Inc.
5850 Oberlin Drive, #340
San Diego,  CA  92121
Applicant Contact Qiyi Xie
Mcra, LLC
803 7th Street
Washington,  DC  20001
Correspondent Contact James E. Mullally, PhD.
Regulation Number862.1155
Classification Product Code
Date Received09/05/2023
Decision Date 05/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No