FDA 510(k)

VITROS BRAHMS PCT Reagent Pack and Calibrators

K番号: K200236 · 2020-02-25

決定日2020-02-25

製品コードPMT

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- MI --- URLや識別子などは原文のままです。

決定大幅同等

医療機器の概要

VITROS BRAHMS PCT Reagent Pack and Calibrators 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 2020-02-25 under 510(k) number K200236. The device is classified under product code PMT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the VITROS BRAHMS PCT Reagent Pack and Calibrators?

VITROS BRAHMS PCT Reagent Pack and Calibrators is a medical device that received FDA 510(k) clearance on 2020-02-25. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K200236.

When did VITROS BRAHMS PCT Reagent Pack and Calibrators receive FDA 510(k) clearance?

VITROS BRAHMS PCT Reagent Pack and Calibrators received FDA 510(k) clearance on 2020-02-25, under 510(k) number K200236.

Who is the listed applicant for VITROS BRAHMS PCT Reagent Pack and Calibrators?

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 BRAHMS PCT Reagent Pack and Calibrators?

The FDA product code for VITROS BRAHMS PCT Reagent Pack and Calibrators is PMT.

申請者としてOrtho Clinical Diagnosticsを記載するその他の記録

K241534VITROS Immunodiagnostic Products Syphilis Reagent Pack K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack K221197VITROS Immunodiagnostic Products Intact PTH II Reagent Pack K231517VITROS Immunodiagnostic Products CEA Reagent Pack K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack K221355VITROS Immuodiagnostic Products CA 125 II Reagent Pack

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