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FDA 510(k)

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

K-Number: K071867 · 2008-04-28

ApplicantParagondx, LLC
Decision Date2008-04-28
Product CodeODV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA is the device name listed in this FDA 510(k) record. The listed applicant is Paragondx, LLC. It received FDA 510(k) clearance on 2008-04-28 under 510(k) number K071867. The device is classified under product code ODV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA?

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA is a medical device that received FDA 510(k) clearance on 2008-04-28. The listed applicant is Paragondx, LLC. The 510(k) number is K071867.

When did RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA receive FDA 510(k) clearance?

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA received FDA 510(k) clearance on 2008-04-28, under 510(k) number K071867.

Who is the listed applicant for RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA?

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

What is the FDA product code for RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA?

The FDA product code for RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA is ODV.

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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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