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FDA 510(k)

AXSYM CYCLOSPORINE

K-Number: K040761 · 2004-04-30

ApplicantAbbott Laboratories, Inc.
Decision Date2004-04-30
Product CodeMKW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXSYM CYCLOSPORINE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories, Inc.. It received FDA 510(k) clearance on 2004-04-30 under 510(k) number K040761. 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 AXSYM CYCLOSPORINE?

AXSYM CYCLOSPORINE is a medical device that received FDA 510(k) clearance on 2004-04-30. The listed applicant is Abbott Laboratories, Inc.. The 510(k) number is K040761.

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

AXSYM CYCLOSPORINE received FDA 510(k) clearance on 2004-04-30, under 510(k) number K040761.

Who is the listed applicant for AXSYM CYCLOSPORINE?

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

What is the FDA product code for AXSYM CYCLOSPORINE?

The FDA product code for AXSYM CYCLOSPORINE is MKW.

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Other records listing Abbott Laboratories, 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.

K090358ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35K061193CREATININEK051213PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPSK040954FOX PLUS PTA CATHETERK023062GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT

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

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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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