The following data is part of a premarket notification filed by Scientific Distributors, Inc. with the FDA for Sdi Prepax Dilukit 29-1000.
| Device ID | K840044 |
| 510k Number | K840044 |
| Device Name: | SDI PREPAX DILUKIT 29-1000 |
| Classification | Flame Emission Photometer For Clinical Use |
| Applicant | SCIENTIFIC DISTRIBUTORS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJO |
| CFR Regulation Number | 862.2540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-06 |
| Decision Date | 1984-03-09 |