The following data is part of a premarket notification filed by Remel Co. with the FDA for Niacin Reagent Strip.
| Device ID | K840981 |
| 510k Number | K840981 |
| Device Name: | NIACIN REAGENT STRIP |
| Classification | Culture Media, Antimycobacteria, Susceptibility Test |
| Applicant | REMEL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | MJD |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-06 |
| Decision Date | 1984-03-23 |