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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K041073
Device Name DOCUMENT SALICYLATE CAL VER
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD.
FREMONT,  CA  94538
Applicant Contact DAVID CASAL
Correspondent
MICROGENICS CORP.
46360 FREMONT BLVD.
FREMONT,  CA  94538
Correspondent Contact DAVID CASAL
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/26/2004
Decision Date 05/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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