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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Thyroid Autoantibody
510(k) Number K841580
Device Name TSH RECEPTOR ANTIBODY KIT 125I TSH
Applicant
Clinetics Corp.
2991 Dow Ave.
Tustin,  CA  92680
Applicant Contact ROA, FR.
Correspondent
Clinetics Corp.
2991 Dow Ave.
Tustin,  CA  92680
Correspondent Contact ROA, FR.
Regulation Number866.5870
Classification Product Code
JZO  
Date Received04/17/1984
Decision Date 10/22/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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