cobas Factor II and Factor V Test
K-Number: K172913 · 2018-01-12
ApplicantRoche Molecular Systems, Inc.
Decision Date2018-01-12
Product CodeNPR
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
cobas Factor II and Factor V Test is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2018-01-12 under approval number K172913. The device is classified under product code NPR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the cobas Factor II and Factor V Test?
cobas Factor II and Factor V Test is a medical device that received FDA 510(k) clearance on 2018-01-12. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K172913.
When was cobas Factor II and Factor V Test approved by the FDA?
cobas Factor II and Factor V Test received FDA 510(k) clearance on 2018-01-12, under approval number K172913.
What company makes cobas Factor II and Factor V Test?
cobas Factor II and Factor V Test is manufactured by Roche Molecular Systems, Inc..
What is the FDA product code for cobas Factor II and Factor V Test?
The FDA product code for cobas Factor II and Factor V Test is NPR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.