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FDA 510(k)

FACTOR II (PROTHROMBIN) G20210A KIT

K-Number: K033612 · 2003-12-18

ApplicantRoche Diagnostics Corp.
Decision Date2003-12-18
Product CodeNPR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACTOR II (PROTHROMBIN) G20210A KIT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2003-12-18 under 510(k) number K033612. 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 FACTOR II (PROTHROMBIN) G20210A KIT?

FACTOR II (PROTHROMBIN) G20210A KIT is a medical device that received FDA 510(k) clearance on 2003-12-18. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K033612.

When did FACTOR II (PROTHROMBIN) G20210A KIT receive FDA 510(k) clearance?

FACTOR II (PROTHROMBIN) G20210A KIT received FDA 510(k) clearance on 2003-12-18, under 510(k) number K033612.

Who is the listed applicant for FACTOR II (PROTHROMBIN) G20210A KIT?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACTOR II (PROTHROMBIN) G20210A KIT?

The FDA product code for FACTOR II (PROTHROMBIN) G20210A KIT is NPR.

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: NPR)

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K250218Xpert® FII & FVCepheidK223046Xpert® FII & FVCepheid®K172913cobas Factor II and Factor V TestRoche Molecular Systems, Inc.K100943INVADER FACTOR IIHologic, Inc.

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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