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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 K843601
Device Name ACCESS HEMAWIPE
Applicant
Medtech Products, Inc.
16101 N. W. 57th. Ave.
Miami,  FL  33014
Applicant Contact BRUCE A CLINTON
Correspondent
Medtech Products, Inc.
16101 N. W. 57th. Ave.
Miami,  FL  33014
Correspondent Contact BRUCE A CLINTON
Regulation Number864.6550
Classification Product Code
KHE  
Date Received09/12/1984
Decision Date 01/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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