K162385 is an FDA 510(k) clearance for the RAPIDEC CARBA NP. This device is classified as a Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates (Class II - Special Controls, product code PTJ).
Submitted by Biomerieux S.A. (Craponne, FR). The FDA issued a Cleared decision on April 27, 2017, 245 days after receiving the submission on August 25, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640. Qualitative Detection Of Carbapenemase Enzymes In Pure Colonies Of Enterobacteriaceae And Pseudomonas Aeruginosa That Have Elevated Mic Values To Any Carbapenem.
| 510(k) Number | K162385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2016 |
| Decision Date | April 27, 2017 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PTJ - Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |
| Definition | Qualitative Detection Of Carbapenemase Enzymes In Pure Colonies Of Enterobacteriaceae And Pseudomonas Aeruginosa That Have Elevated Mic Values To Any Carbapenem |