The following data is part of a premarket notification filed by Scientific Device Laboratory, Inc. with the FDA for Sdl Listeria Monocytogenes Control.
| Device ID | K840503 |
| 510k Number | K840503 |
| Device Name: | SDL LISTERIA MONOCYTOGENES CONTROL |
| Classification | Antigens, Slide And Tube, All Types, Listeria Monocytogenes |
| Applicant | SCIENTIFIC DEVICE LABORATORY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GSI |
| CFR Regulation Number | 866.3355 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-06 |
| Decision Date | 1984-03-23 |