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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 K852224
Device Name LEE-BEAD TSH(EIA)
Applicant
Lecco Diagnostics, Inc.
21705 Evergreen
P.O. Box 5126
Southfield,  MI  48075
Applicant Contact LEE, PH.D.
Correspondent
Lecco Diagnostics, Inc.
21705 Evergreen
P.O. Box 5126
Southfield,  MI  48075
Correspondent Contact LEE, PH.D.
Regulation Number862.1690
Classification Product Code
JLW  
Date Received05/22/1985
Decision Date 07/09/1985
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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