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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 K961629
Device Name THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST
Applicant
Teco Diagnostics
911 Via Rodeo
Placentia,  CA  92670
Applicant Contact K C CHEN
Correspondent
Teco Diagnostics
911 Via Rodeo
Placentia,  CA  92670
Correspondent Contact K C CHEN
Regulation Number862.1690
Classification Product Code
JLW  
Date Received04/26/1996
Decision Date 09/11/1996
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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