K840503 is an FDA 510(k) clearance for the SDL LISTERIA MONOCYTOGENES CONTROL. This device is classified as a Antigens, Slide And Tube, All Types, Listeria Monocytogenes (Class I - General Controls, product code GSI).
Submitted by Scientific Device Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984, 46 days after receiving the submission on February 6, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3355.
| 510(k) Number | K840503 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1984 |
| Decision Date | March 23, 1984 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GSI — Antigens, Slide And Tube, All Types, Listeria Monocytogenes |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3355 |