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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Acetaminophen
510(k) Number K202644
Device Name Acetaminophen
Applicant
Sekisui Diagnostics P.E.I., Inc.
70 Watts Ave.
Charlottetown,  CA C1E 2B9
Applicant Contact Penny White
Correspondent
Sekisui Diagnostics P.E.I., Inc.
70 Watts Ave.
Charlottetown,  CA C1E 2B9
Correspondent Contact Penny White
Regulation Number862.3030
Classification Product Code
LDP  
Date Received09/11/2020
Decision Date 02/18/2022
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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