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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 K800203
Device Name RIA PHASE T4
Applicant
BOEHRINGER MANNHEIM CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BOEHRINGER MANNHEIM CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1700
Classification Product Code
CDX  
Date Received01/30/1980
Decision Date 03/19/1980
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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