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FDA 510(k)

VITROS BRAHMS PCT Reagent Pack and Calibrators

K-Number: K200236 · 2020-02-25

ApplicantOrtho Clinical Diagnostics
Decision Date2020-02-25
Product CodePMT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Ortho Clinical Diagnostics as applicant

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Related Devices (Code: PMT)

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.

K181002Atellica IM BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.K160911VIDAS B.R.A.H.M.S. PCT (PCT)bioMerieux, Inc.K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics

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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