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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 K110761
Device Name MICT TSH
Applicant
Magnabiosciences, LLC
6325 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact JAMES L WYATT
Correspondent
Magnabiosciences, LLC
6325 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact JAMES L WYATT
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
JJQ  
Date Received03/18/2011
Decision Date 03/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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