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FDA 510(k)

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

K-Number: K160729 · 2016-06-13

ApplicantRoche Diagnostics
Decision Date2016-06-13
Product CodePMT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2016-06-13 under 510(k) number K160729. 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 Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5?

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 is a medical device that received FDA 510(k) clearance on 2016-06-13. The listed applicant is Roche Diagnostics. The 510(k) number is K160729.

When did Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 receive FDA 510(k) clearance?

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 received FDA 510(k) clearance on 2016-06-13, under 510(k) number K160729.

Who is the listed applicant for Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5?

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

What is the FDA product code for Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5?

The FDA product code for Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 is PMT.

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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.

K200236VITROS BRAHMS PCT Reagent Pack and CalibratorsOrtho Clinical DiagnosticsK181002Atellica IM BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.K160911VIDAS B.R.A.H.M.S. PCT (PCT)bioMerieux, 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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