FDA 510(k), K110061, CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL

FDA 510(k), K110061, CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL

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510(K) Number: K110061
Device Name: CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
Manufacturer: Ernest Joseph
Device Classification Name: Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation Number: JJX
Classification Product Code: 01/10/2011
Date Received: 09/21/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry

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