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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 K860288
Device Name ECHOCLONAL HTSH IRMA
Applicant
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Applicant Contact LYNN C SHANTA
Correspondent
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Correspondent Contact LYNN C SHANTA
Regulation Number862.1690
Classification Product Code
JLW  
Date Received01/28/1986
Decision Date 04/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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