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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cyanomethemoglobin Reagent And Standard Solution
510(k) Number K883683
Device Name HEMOGLOBIN
Applicant
Tech-Co, Inc.
24111 Beverly
Oak Park,  MI  48237
Applicant Contact CHEN, PH.D.
Correspondent
Tech-Co, Inc.
24111 Beverly
Oak Park,  MI  48237
Correspondent Contact CHEN, PH.D.
Regulation Number864.7500
Classification Product Code
GJZ  
Date Received08/29/1988
Decision Date 10/06/1988
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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