The following data is part of a premarket notification filed by Miles Pharmaceuticals with the FDA for Mezlin Diagnostic Reagent.
| Device ID | K820578 |
| 510k Number | K820578 |
| Device Name: | MEZLIN DIAGNOSTIC REAGENT |
| Classification | Susceptibility Test Powders, Antimicrobial |
| Applicant | MILES PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTT |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-03 |
| Decision Date | 1982-05-12 |