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 a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2020-02-25 under approval 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. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K200236.
When was VITROS BRAHMS PCT Reagent Pack and Calibrators approved by the FDA?
VITROS BRAHMS PCT Reagent Pack and Calibrators received FDA 510(k) clearance on 2020-02-25, under approval number K200236.
What company makes VITROS BRAHMS PCT Reagent Pack and Calibrators?
VITROS BRAHMS PCT Reagent Pack and Calibrators is manufactured by Ortho Clinical Diagnostics.
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.
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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.