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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 K942658
Device Name NEOSCREEN ELISA TSH
Applicant
Pantex, Div. Bio-Analysis, Inc.
1737 21st St.
Santa Monica,  CA  90404
Applicant Contact NANCY CHOW
Correspondent
Pantex, Div. Bio-Analysis, Inc.
1737 21st St.
Santa Monica,  CA  90404
Correspondent Contact NANCY CHOW
Regulation Number862.1690
Classification Product Code
JLW  
Date Received06/06/1994
Decision Date 02/24/1995
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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