K855106 is an FDA 510(k) clearance for the IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645. This device is classified as a Susceptibility Test Powders, Antimicrobial (Class II - Special Controls, product code JTT).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on March 6, 1986, 73 days after receiving the submission on December 23, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K855106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1985 |
| Decision Date | March 06, 1986 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTT — Susceptibility Test Powders, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |