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FDA 510(k)

CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

K-Number: K023065 · 2002-10-16

ApplicantDade Behring, Inc.
Decision Date2002-10-16
Product CodeMKW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE 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 2002-10-16 under 510(k) number K023065. 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 (CSA) FLEX REAGENT CARTRIDGE?

CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 2002-10-16. The listed applicant is Dade Behring, Inc.. The 510(k) number is K023065.

When did CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE receive FDA 510(k) clearance?

CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 2002-10-16, under 510(k) number K023065.

Who is the listed applicant for CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE?

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 (CSA) FLEX REAGENT CARTRIDGE?

The FDA product code for CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE is MKW.

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Other records listing Dade Behring, Inc. 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.

K093848PT-MULTI-CALIBRATOR, MODEL OPAT07K081161DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYSTK081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEMK071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

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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.K053061EMIT 2000 CYCLOSPORINE SPECIFIC ASSAYDade Behring, Inc.K052017CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108Dade Behring, 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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