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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Occult Blood Analyzer
510(k) Number K200754
Device Name Hemosure Accu-Reader A100
Applicant
W.H.P.M., Inc.
5358 N. Irwindale Ave.
Irwindale,  CA  91706
Applicant Contact Farokh Etemedieh
Correspondent
Smith Associates
5358 N. Irwindale Ave.
Irwindale,  CA  91706
Correspondent Contact Farokh Etemadieh
Regulation Number864.6550
Classification Product Code
OOX  
Date Received03/23/2020
Decision Date 06/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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