K864803 is an FDA 510(k) clearance for the GC-LECT(TM). This device is classified as a Culture Media, For Isolation Of Pathogenic Neisseria (Class II - Special Controls, product code JTY).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 3, 1987, 56 days after receiving the submission on December 9, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2410.
| 510(k) Number | K864803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1986 |
| Decision Date | February 03, 1987 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTY — Culture Media, For Isolation Of Pathogenic Neisseria |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.2410 |