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FDA 510(k)

EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR

K-Number: K083487 · 2009-03-30

ApplicantSiemens Healthcare Diagnostics
Decision Date2009-03-30
Product CodeNRP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2009-03-30 under 510(k) number K083487. 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 EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR?

EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR is a medical device that received FDA 510(k) clearance on 2009-03-30. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K083487.

When did EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR receive FDA 510(k) clearance?

EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR received FDA 510(k) clearance on 2009-03-30, under 510(k) number K083487.

Who is the listed applicant for EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR?

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

What is the FDA product code for EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR?

The FDA product code for EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR 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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