RAPIDEC CARBA NP
K-Number: K162385 · 2017-04-27
ApplicantBiomerieux S.A.
Decision Date2017-04-27
Product CodePTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
RAPIDEC CARBA NP is a medical device manufactured by Biomerieux S.A.. It received FDA 510(k) clearance on 2017-04-27 under approval number K162385. The device is classified under product code PTJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RAPIDEC CARBA NP?
RAPIDEC CARBA NP is a medical device that received FDA 510(k) clearance on 2017-04-27. It is manufactured by Biomerieux S.A.. The 510(k) number is K162385.
When was RAPIDEC CARBA NP approved by the FDA?
RAPIDEC CARBA NP received FDA 510(k) clearance on 2017-04-27, under approval number K162385.
What company makes RAPIDEC CARBA NP?
RAPIDEC CARBA NP is manufactured by Biomerieux S.A..
What is the FDA product code for RAPIDEC CARBA NP?
The FDA product code for RAPIDEC CARBA NP is PTJ.
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Related Devices (Code: PTJ)
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.