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510(k) K140426

ANTHRACIS REAL-TIME PCR ASSAY by Centers For Disease Control and Prevention (Cdc) — Product Code NHT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 22, 2014
Date Received: February 19, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Assay, Nucleic Acid Amplification, Bacillus Anthracis
Device Class: Class II
Regulation Number: 866.3045
Review Panel: MI
Submission Type

An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.

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