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FDA 510(k)

Lumipulse G whole PTH

K-Number: K190702 · 2019-08-30

ApplicantFujirebio Diagnostics,Inc.
Decision Date2019-08-30
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Lumipulse G whole PTH is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2019-08-30 under 510(k) number K190702. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumipulse G whole PTH?

Lumipulse G whole PTH is a medical device that received FDA 510(k) clearance on 2019-08-30. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K190702.

When did Lumipulse G whole PTH receive FDA 510(k) clearance?

Lumipulse G whole PTH received FDA 510(k) clearance on 2019-08-30, under 510(k) number K190702.

Who is the listed applicant for Lumipulse G whole PTH?

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

What is the FDA product code for Lumipulse G whole PTH?

The FDA product code for Lumipulse G whole PTH is CEW.

Other records listing Fujirebio Diagnostics,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.

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Related Devices (Code: CEW)

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.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

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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