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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K853977
Device Name BETA-TSH-IRMA
Applicant
Leeco Diagnostics, Inc.
21705 Evergreen
P.O. Box 5126
Southfield,  MI  48075
Applicant Contact JAMES P LEE
Correspondent
Leeco Diagnostics, Inc.
21705 Evergreen
P.O. Box 5126
Southfield,  MI  48075
Correspondent Contact JAMES P LEE
Regulation Number862.1690
Classification Product Code
JLW  
Date Received09/26/1985
Decision Date 10/22/1985
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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