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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 K962216
Device Name TSH (MICROWELL) ELISA
Applicant
Biomerica, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Applicant Contact JAY SINGH
Correspondent
Biomerica, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Correspondent Contact JAY SINGH
Regulation Number862.1690
Classification Product Code
JLW  
Date Received06/10/1996
Decision Date 09/19/1996
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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