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FDA 510(k)

ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR

K-Number: K071455 · 2008-09-11

ApplicantSiemens Medical Solutions Diagnostics
Decision Date2008-09-11
Product CodeMKW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions Diagnostics. It received FDA 510(k) clearance on 2008-09-11 under 510(k) number K071455. The device is classified under product code MKW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR?

ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR is a medical device that received FDA 510(k) clearance on 2008-09-11. The listed applicant is Siemens Medical Solutions Diagnostics. The 510(k) number is K071455.

When did ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR receive FDA 510(k) clearance?

ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR received FDA 510(k) clearance on 2008-09-11, under 510(k) number K071455.

Who is the listed applicant for ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR?

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

What is the FDA product code for ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR?

The FDA product code for ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR is MKW.

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Other records listing Siemens Medical Solutions Diagnostics 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.

K100910IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6K091984IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6K081895ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORSK073537NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265K072658ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORSK072794IMMULITE 2500 OM-MA, MODEL L5KOP

View all 11 devices →

Related Devices (Code: MKW)

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.

K080751ARCHITECT CYCLOSPORINEFujirebio Diagnostics,Inc.K081992DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108Siemens Healthcare Diagnostics, Inc.K062236DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGEDade Behring, Inc.K053061EMIT 2000 CYCLOSPORINE SPECIFIC ASSAYDade Behring, Inc.K052017CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108Dade Behring, Inc.K040761AXSYM CYCLOSPORINEAbbott Laboratories, 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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