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FDA 510(k)

ACCESS OV MONITOR ASSAY

K-Number: K031297 · 2003-05-02

ApplicantBeckman Coulter, Inc.
Decision Date2003-05-02
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACCESS OV MONITOR ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2003-05-02 under 510(k) number K031297. The device is classified under product code LTK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS OV MONITOR ASSAY?

ACCESS OV MONITOR ASSAY is a medical device that received FDA 510(k) clearance on 2003-05-02. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K031297.

When did ACCESS OV MONITOR ASSAY receive FDA 510(k) clearance?

ACCESS OV MONITOR ASSAY received FDA 510(k) clearance on 2003-05-02, under 510(k) number K031297.

Who is the listed applicant for ACCESS OV MONITOR ASSAY?

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

What is the FDA product code for ACCESS OV MONITOR ASSAY?

The FDA product code for ACCESS OV MONITOR ASSAY is LTK.

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Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: LTK)

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.

K240479Access OV MonitorBeckman Coulter, Inc.K213510IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd.K221355VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical DiagnosticsK200199ADVIA Centaur CA 125IISiemens Healthcare Diagnostics, Inc.K100321DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604Siemens Healthcare DiagnosticsK080469VIDAS CA 15-3 ASSAYbioMerieux, 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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