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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
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