510(k) K162385
K162385 is an FDA 510(k) premarket notification submitted by Biomerieux S.A. for the device "RAPIDEC CARBA NP". The FDA issued a decision of Substantially Equivalent on April 27, 2017. The device falls under product code PTJ (Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates), a Class II device regulated under 21 CFR 866.1640. Biomerieux S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2017
- Date Received
- August 25, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem