The following data is part of a premarket notification filed by General Diagnostics with the FDA for Cefuroxime 30mcg. Suscep Disk.
| Device ID | K832653 |
| 510k Number | K832653 |
| Device Name: | CEFUROXIME 30MCG. SUSCEP 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 | 1983-08-08 |
| Decision Date | 1983-10-14 |