The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Norfloxacin 10 Mcg Susceptibility Disk.
| Device ID | K864848 |
| 510k Number | K864848 |
| Device Name: | NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Contact | Toni M Stifano |
| Correspondent | Toni M Stifano ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-10 |
| Decision Date | 1987-03-17 |