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FDA 510(k)

ARCHITECT CYCLOSPORINE

K-Number: K080751 · 2008-09-11

ApplicantFujirebio Diagnostics,Inc.
Decision Date2008-09-11
Product CodeMKW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHITECT CYCLOSPORINE 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 2008-09-11 under 510(k) number K080751. 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 ARCHITECT CYCLOSPORINE?

ARCHITECT CYCLOSPORINE is a medical device that received FDA 510(k) clearance on 2008-09-11. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K080751.

When did ARCHITECT CYCLOSPORINE receive FDA 510(k) clearance?

ARCHITECT CYCLOSPORINE received FDA 510(k) clearance on 2008-09-11, under 510(k) number K080751.

Who is the listed applicant for ARCHITECT CYCLOSPORINE?

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 CYCLOSPORINE?

The FDA product code for ARCHITECT CYCLOSPORINE is MKW.

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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.

K071455ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATORSiemens Medical Solutions DiagnosticsK081992DIMENSION 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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