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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 triiodothyronine
510(k) Number K820251
Device Name T4 DIAGNOSTIC KIT
Applicant
DIAGNOSTIC REAGENTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DIAGNOSTIC REAGENTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1710
Classification Product Code
CDP  
Date Received01/29/1982
Decision Date 05/05/1982
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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