K811434 is an FDA 510(k) clearance for the SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS. This device is classified as a Kit, Identification, Enterobacteriaceae (Class I - General Controls, product code JSS).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on June 26, 1981, 35 days after receiving the submission on May 22, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K811434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1981 |
| Decision Date | June 26, 1981 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSS — Kit, Identification, Enterobacteriaceae |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |