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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 K844583
Device Name TSH-STAT
Applicant
Nuclear Medical Laboratories, Inc.
1800 Hurd Dr.
P.O. Box 2860
Irving,  TX  75061
Applicant Contact ROBERT D WURZEL
Correspondent
Nuclear Medical Laboratories, Inc.
1800 Hurd Dr.
P.O. Box 2860
Irving,  TX  75061
Correspondent Contact ROBERT D WURZEL
Regulation Number862.1690
Classification Product Code
JLW  
Date Received11/23/1984
Decision Date 03/05/1985
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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