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510(k) Premarket Notification Database

Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) NumberK041073
Device NameDOCUMENT SALICYLATE CAL VER
Applicant
MICROGENICS CORP.
46360 fremont blvd.
fremont,  CA  94538
Contactdavid casal
Regulation Number862.1660
Classification Product Code
JJY
Date Received05/10/2004
Decision Date 05/21/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Statement/Summary/Purged Status Summary only
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No

Database Updated 02/06/2009

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