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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 K905769
Device Name IMMULITE HS-TSH
Applicant
Cirrus Diagnostics, Inc.
P.O. Box 15
Chester,  NJ  07930
Applicant Contact ROBERT FENNELL
Correspondent
Cirrus Diagnostics, Inc.
P.O. Box 15
Chester,  NJ  07930
Correspondent Contact ROBERT FENNELL
Regulation Number862.1690
Classification Product Code
JLW  
Date Received12/27/1990
Decision Date 01/31/1991
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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