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FDA 510(k)

ARCHITECT SIROLIMUS ASSAY

K-Number: K070822 · 2007-09-28

ApplicantFujirebio Diagnostics,Inc.
Decision Date2007-09-28
Product CodeNRP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARCHITECT SIROLIMUS ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2007-09-28 under 510(k) number K070822. The device is classified under product code NRP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT SIROLIMUS ASSAY?

ARCHITECT SIROLIMUS ASSAY is a medical device that received FDA 510(k) clearance on 2007-09-28. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K070822.

When did ARCHITECT SIROLIMUS ASSAY receive FDA 510(k) clearance?

ARCHITECT SIROLIMUS ASSAY received FDA 510(k) clearance on 2007-09-28, under 510(k) number K070822.

Who is the listed applicant for ARCHITECT SIROLIMUS ASSAY?

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

What is the FDA product code for ARCHITECT SIROLIMUS ASSAY?

The FDA product code for ARCHITECT SIROLIMUS ASSAY is NRP.

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Related Devices (Code: NRP)

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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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