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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 K863859
Device Name TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM
Applicant
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Applicant Contact BRUNI, PH.D.
Correspondent
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Correspondent Contact BRUNI, PH.D.
Regulation Number862.1690
Classification Product Code
JLW  
Date Received10/03/1986
Decision Date 11/21/1986
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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