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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 K920856
Device Name VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS
Applicant
Hycor Biomedical, Inc.
217 Read St.
P.O. Box 9731
Portland,  MA  04104
Applicant Contact JAN L TROTT
Correspondent
Hycor Biomedical, Inc.
217 Read St.
P.O. Box 9731
Portland,  MA  04104
Correspondent Contact JAN L TROTT
Regulation Number862.1690
Classification Product Code
JLW  
Date Received02/18/1992
Decision Date 03/26/1992
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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