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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Iron (Non-Heme)
510(k) Number K901561
Device Name IRON/TOTAL IRON BINDING CAPACITY
Applicant
Tech-Co, Inc.
1856 Star-Batt Dr.
Rochester Hills,  MI  48309
Applicant Contact CHEN, PH.D.
Correspondent
Tech-Co, Inc.
1856 Star-Batt Dr.
Rochester Hills,  MI  48309
Correspondent Contact CHEN, PH.D.
Regulation Number862.1410
Classification Product Code
JIY  
Subsequent Product Code
JMO  
Date Received04/03/1990
Decision Date 05/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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