The following data is part of a premarket notification filed by Merck, Sharp & Dohme with the FDA for Norfloxacin Susceptibility Powder.
| Device ID | K864442 |
| 510k Number | K864442 |
| Device Name: | NORFLOXACIN SUSCEPTIBILITY POWDER |
| Classification | Susceptibility Test Powders, Antimicrobial |
| Applicant | MERCK, SHARP & DOHME DIVISION OF MERCK & CO., INC. West Point, PA 19486 |
| Contact | Blois, Phd |
| Correspondent | Blois, Phd MERCK, SHARP & DOHME DIVISION OF MERCK & CO., INC. West Point, PA 19486 |
| Product Code | JTT |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-12 |
| Decision Date | 1986-12-11 |