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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 K854087
Device Name NML TSH IRMA
Applicant
Organon Teknika Corp.
P.O. Box 152860
Irving,  TX  75015
Applicant Contact ROBERT WURZEL
Correspondent
Organon Teknika Corp.
P.O. Box 152860
Irving,  TX  75015
Correspondent Contact ROBERT WURZEL
Regulation Number862.1690
Classification Product Code
JLW  
Date Received10/07/1985
Decision Date 10/25/1985
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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