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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, secondary
510(k) Number K043095
Device Name ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50416
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact KAY A TAYLOR
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50416
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact KAY A TAYLOR
Regulation Number862.1150
Classification Product Code
JIT  
Date Received11/09/2004
Decision Date 11/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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