RAPIDEC CARBA NP— 510(k) K162385

Substantially Equivalent

Biomerieux S.A.

FDA 510(k) clearance K162385 for RAPIDEC CARBA NP, Substantially Equivalent on 2017-04-27. Applicant: Biomerieux S.A.. Device class: 2.

Clearance details

Applicant: Biomerieux S.A.
Product code: Code PTJ
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2016-08-25
Decision date: 2017-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Craponne, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.