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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 K780639
Device Name EMIT CENTRIFICHEM THYROXINE ASSAY
Applicant
Syva Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Syva Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1700
Classification Product Code
CDX  
Date Received04/17/1978
Decision Date 05/03/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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