510(k) K172913

cobas Factor II and Factor V Test by Roche Molecular Systems, Inc. — Product Code NPR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 12, 2018
Date Received: September 25, 2017
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Device Class: Class II
Regulation Number: 864.7280
Review Panel: PA
Submission Type

In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

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510(k) K172913

Clearance Details

Device Classification

Other clearances by Roche Molecular Systems, Inc.

Other clearances for product code NPR