The following data is part of a premarket notification filed by General Diagnostics with the FDA for Moxalactom 30mcg Antimicrobial Sus. Disk.
| Device ID | K812993 |
| 510k Number | K812993 |
| Device Name: | MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | GENERAL DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-26 |
| Decision Date | 1981-11-10 |