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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) 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. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K172913.

When did cobas Factor II and Factor V Test receive FDA 510(k) clearance?

cobas Factor II and Factor V Test received FDA 510(k) clearance on 2018-01-12, under 510(k) number K172913.

Who is the listed applicant for cobas Factor II and Factor V Test?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Roche Molecular Systems, Inc. as applicant

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Related Devices (Code: NPR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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