K912897 is an FDA 510(k) clearance for the SCEPTOR IDENTIFICATION SYSTEM. This device is classified as a Gram Negative Identification Panel (Class I - General Controls, product code LQM).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 28, 1991, 119 days after receiving the submission on July 1, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K912897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1991 |
| Decision Date | October 28, 1991 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LQM — Gram Negative Identification Panel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |