K782117 is an FDA 510(k) clearance for the MARTIN-LEWIS MEDIUM. This device is classified as a Culture Media, For Isolation Of Pathogenic Neisseria (Class II — Special Controls, product code JTY).
Submitted by Prepared Media Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1979, 36 days after receiving the submission on December 27, 1978.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2410.
| 510(k) Number | K782117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1978 |
| Decision Date | February 01, 1979 |
| Days to Decision | 36 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 |