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FDA 510(k)

INVADER FACTOR II

K-Number: K100943 · 2011-06-02

ApplicantHologic, Inc.
Decision Date2011-06-02
Product CodeNPR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INVADER FACTOR II is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2011-06-02 under 510(k) number K100943. 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 INVADER FACTOR II?

INVADER FACTOR II is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Hologic, Inc.. The 510(k) number is K100943.

When did INVADER FACTOR II receive FDA 510(k) clearance?

INVADER FACTOR II received FDA 510(k) clearance on 2011-06-02, under 510(k) number K100943.

Who is the listed applicant for INVADER FACTOR II?

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

What is the FDA product code for INVADER FACTOR II?

The FDA product code for INVADER FACTOR II is NPR.

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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.

K250218Xpert® FII & FVCepheidK223046Xpert® FII & FVCepheid®K172913cobas Factor II and Factor V TestRoche Molecular Systems, Inc.K033612FACTOR II (PROTHROMBIN) G20210A KITRoche Diagnostics Corp.

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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