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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 K861918
Device Name V-TREND EIA TSH
Applicant
V-Tech, Inc.
270 E. Bonita Ave.
Pomona,  CA  91767
Applicant Contact HERRANEN, PHD
Correspondent
V-Tech, Inc.
270 E. Bonita Ave.
Pomona,  CA  91767
Correspondent Contact HERRANEN, PHD
Regulation Number862.1690
Classification Product Code
JLW  
Date Received05/19/1986
Decision Date 07/02/1986
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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