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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 K840088
Device Name BIODEX ACT-O-KIT TSH-RIA-
Applicant
Biodan Medical Systems, Ltd.
P.O.B. 2012
Rehovot 76120
Israel,  IL
Correspondent
Biodan Medical Systems, Ltd.
P.O.B. 2012
Rehovot 76120
Israel,  IL
Regulation Number862.1690
Classification Product Code
JLW  
Date Received01/10/1984
Decision Date 05/07/1984
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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