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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 K912852
Device Name STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 520672
MIAMI,  FL  33152
Applicant Contact JEANNE-MARIE VARGA
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 520672
MIAMI,  FL  33152
Correspondent Contact JEANNE-MARIE VARGA
Regulation Number862.1690
Classification Product Code
JLW  
Date Received06/28/1991
Decision Date 09/27/1991
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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