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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K173212
Device Name Instant-view-PLUS immunochemical Fecal Occult Blood Test
Applicant
Alfa Scientific Designs, Inc.
13200 Gregg St.
Poway,  CA  92064
Applicant Contact Wen Hua Fan
Correspondent
Alfa Scientific Designs, Inc.
13200 Gregg St.
Poway,  CA  92064
Correspondent Contact Wen Hua Fan
Regulation Number864.6550
Classification Product Code
KHE  
Date Received10/02/2017
Decision Date 02/15/2018
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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