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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K932607
Device Name COBAS(R) CORE FT4 EIA
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
1080 U.S. HIGHWAY 202
BRANCHBURG,  NJ  08876 -3771
Applicant Contact RITA SMITH
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
1080 U.S. HIGHWAY 202
BRANCHBURG,  NJ  08876 -3771
Correspondent Contact RITA SMITH
Regulation Number862.1695
Classification Product Code
CEC  
Date Received05/28/1993
Decision Date 01/24/1994
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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