K872081 is an FDA 510(k) clearance for the CIPRO (TM) DIAGNOSTIC POWDER. This device is classified as a Susceptibility Test Powders, Antimicrobial (Class II - Special Controls, product code JTT).
Submitted by Miles Pharmaceuticals (West Haven, US). The FDA issued a Cleared decision on June 15, 1987, 17 days after receiving the submission on May 29, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K872081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1987 |
| Decision Date | June 15, 1987 |
| Days to Decision | 17 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 |