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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 K821101
Device Name TOTAL RADIOIMMUNOASSAY KIT
Applicant
BIOCLINICAL GROUP
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIOCLINICAL GROUP
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1700
Classification Product Code
CDX  
Date Received04/20/1982
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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