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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Thyroxine
510(k) Number K920766
Device Name T4 EIA BEAD ASSAY
Applicant
Tech-Co, Inc.
1856 Star-Batt Dr.
Rochester Hills,  MI  48309
Applicant Contact CHEN
Correspondent
Tech-Co, Inc.
1856 Star-Batt Dr.
Rochester Hills,  MI  48309
Correspondent Contact CHEN
Regulation Number862.1700
Classification Product Code
CDX  
Date Received02/19/1992
Decision Date 04/17/1992
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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