The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Azlin Azlocilin Sodium-diag. Reagent.
| Device ID | K830758 |
| 510k Number | K830758 |
| Device Name: | AZLIN AZLOCILIN SODIUM-DIAG. REAGENT |
| Classification | Susceptibility Test Powders, Antimicrobial |
| Applicant | MILES LABORATORIES, INC. 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 | 1983-03-10 |
| Decision Date | 1983-05-25 |