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FDA 510(k)

CEDIA CYCLOSPORINE PLUS ASSAY

K-Number: K023208 · 2002-10-24

ApplicantMicrogenics Corp.
Decision Date2002-10-24
Product CodeMKW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CEDIA CYCLOSPORINE PLUS ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2002-10-24 under 510(k) number K023208. 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 CEDIA CYCLOSPORINE PLUS ASSAY?

CEDIA CYCLOSPORINE PLUS ASSAY is a medical device that received FDA 510(k) clearance on 2002-10-24. The listed applicant is Microgenics Corp.. The 510(k) number is K023208.

When did CEDIA CYCLOSPORINE PLUS ASSAY receive FDA 510(k) clearance?

CEDIA CYCLOSPORINE PLUS ASSAY received FDA 510(k) clearance on 2002-10-24, under 510(k) number K023208.

Who is the listed applicant for CEDIA CYCLOSPORINE PLUS ASSAY?

The FDA 510(k) record lists Microgenics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEDIA CYCLOSPORINE PLUS ASSAY?

The FDA product code for CEDIA CYCLOSPORINE PLUS ASSAY is MKW.

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Other records listing Microgenics Corp. 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.

K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK123271ABBOTT PHENOBARBITAL ASSAYK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101742THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAYK101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

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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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