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 a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2016-06-13 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K160729.
When was Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 approved by the FDA?
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 received FDA 510(k) clearance on 2016-06-13, under approval number K160729.
What company makes Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5?
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 is manufactured by Roche Diagnostics.
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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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.