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FDA 510(k)

ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY

K-Number: K042411 · 2005-04-07

ApplicantAxis-Shield , Ltd.
Decision Date2005-04-07
Product CodeNRP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield , Ltd.. It received FDA 510(k) clearance on 2005-04-07 under 510(k) number K042411. 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 ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY?

ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2005-04-07. The listed applicant is Axis-Shield , Ltd.. The 510(k) number is K042411.

When did ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 2005-04-07, under 510(k) number K042411.

Who is the listed applicant for ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY?

The FDA 510(k) record lists Axis-Shield , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY?

The FDA product code for ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY is NRP.

Related Clinical Trials

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Other records listing Axis-Shield , Ltd. as applicant

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.

K001981DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500

Related Devices (Code: NRP)

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.

K083487EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATORSiemens Healthcare DiagnosticsK081857DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306Siemens Healthcare Diagnostics, Inc.K070822ARCHITECT SIROLIMUS ASSAYFujirebio Diagnostics,Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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