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FDA 510(k)

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack

K-Number: K221197 · 2023-09-05

ApplicantOrtho Clinical Diagnostics
Decision Date2023-09-05
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2023-09-05 under 510(k) number K221197. 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 VITROS Immunodiagnostic Products Intact PTH II Reagent Pack?

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack is a medical device that received FDA 510(k) clearance on 2023-09-05. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K221197.

When did VITROS Immunodiagnostic Products Intact PTH II Reagent Pack receive FDA 510(k) clearance?

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack received FDA 510(k) clearance on 2023-09-05, under 510(k) number K221197.

Who is the listed applicant for VITROS Immunodiagnostic Products Intact PTH II Reagent Pack?

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

What is the FDA product code for VITROS Immunodiagnostic Products Intact PTH II Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products Intact PTH II Reagent Pack is CEW.

Other records listing Ortho Clinical Diagnostics as applicant

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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.K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA 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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