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FDA 510(k)

IMMULITE 2500 OM-MA, MODEL L5KOP

K-Number: K072794 · 2007-11-05

ApplicantSiemens Medical Solutions Diagnostics
Decision Date2007-11-05
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2500 OM-MA, MODEL L5KOP is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions Diagnostics. It received FDA 510(k) clearance on 2007-11-05 under 510(k) number K072794. 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 IMMULITE 2500 OM-MA, MODEL L5KOP?

IMMULITE 2500 OM-MA, MODEL L5KOP is a medical device that received FDA 510(k) clearance on 2007-11-05. The listed applicant is Siemens Medical Solutions Diagnostics. The 510(k) number is K072794.

When did IMMULITE 2500 OM-MA, MODEL L5KOP receive FDA 510(k) clearance?

IMMULITE 2500 OM-MA, MODEL L5KOP received FDA 510(k) clearance on 2007-11-05, under 510(k) number K072794.

Who is the listed applicant for IMMULITE 2500 OM-MA, MODEL L5KOP?

The FDA 510(k) record lists Siemens Medical Solutions Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE 2500 OM-MA, MODEL L5KOP?

The FDA product code for IMMULITE 2500 OM-MA, MODEL L5KOP is LTK.

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Other records listing Siemens Medical Solutions Diagnostics 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.

K100910IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6K091984IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6K081895ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORSK071455ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATORK073537NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265K072658ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS

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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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