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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Thyroxine
510(k) Number K933426
Device Name STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
Applicant
BAXTER DIAGNOSTICS, INC.
P.O. BOX 520672
MIAMI,  FL  33152
Applicant Contact RONALD H LENTSCH
Correspondent
BAXTER DIAGNOSTICS, INC.
P.O. BOX 520672
MIAMI,  FL  33152
Correspondent Contact RONALD H LENTSCH
Regulation Number862.1700
Classification Product Code
CDX  
Date Received07/13/1993
Decision Date 08/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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