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FDA 510(k)

EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

K-Number: K053061 · 2006-02-06

ApplicantDade Behring, Inc.
Decision Date2006-02-06
Product CodeMKW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2006-02-06 under 510(k) number K053061. 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 EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY?

EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY is a medical device that received FDA 510(k) clearance on 2006-02-06. The listed applicant is Dade Behring, Inc.. The 510(k) number is K053061.

When did EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY receive FDA 510(k) clearance?

EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY received FDA 510(k) clearance on 2006-02-06, under 510(k) number K053061.

Who is the listed applicant for EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY?

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

What is the FDA product code for EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY?

The FDA product code for EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY 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.

K080751ARCHITECT CYCLOSPORINEFujirebio Diagnostics,Inc.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.K052017CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108Dade Behring, Inc.K040761AXSYM CYCLOSPORINEAbbott Laboratories, 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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