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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 K234091
Device Name Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
Applicant
Genalyte, Inc.
6620 Mesa Ridge Rd.
San Diego,  CA  92121
Applicant Contact Sasi Mudumba
Correspondent
Genalyte, Inc.
6620 Mesa Ridge Rd.
San Diego,  CA  92121
Correspondent Contact Sasi Mudumba
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
JJE  
Date Received12/26/2023
Decision Date 07/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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