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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K770070
Device Name ENIT ABA 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
KLI  
Date Received01/13/1977
Decision Date 01/21/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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