K854099 is an FDA 510(k) clearance for the SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL. This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II - Special Controls, product code JWY).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on November 14, 1985, 38 days after receiving the submission on October 7, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K854099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1985 |
| Decision Date | November 14, 1985 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JWY — Manual Antimicrobial Susceptibility Test Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |