FDA 510(k)

CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108

K-Number: K052017 · 2005-09-01

Decision Date2005-09-01

Product CodeMKW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 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 2005-09-01 under 510(k) number K052017. 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 CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108?

CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 is a medical device that received FDA 510(k) clearance on 2005-09-01. The listed applicant is Dade Behring, Inc.. The 510(k) number is K052017.

When did CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 receive FDA 510(k) clearance?

CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 received FDA 510(k) clearance on 2005-09-01, under 510(k) number K052017.

Who is the listed applicant for CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108?

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 CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108?

The FDA product code for CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 is MKW.

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Other records listing Dade Behring, Inc. as applicant

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Related Devices (Code: MKW)

K080751ARCHITECT CYCLOSPORINEFujirebio Diagnostics,Inc.K071455ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATORSiemens Medical Solutions Diagnostics 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.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.