JTT — Susceptibility Test Powders, Antimicrobial Class II
FDA product code JTT covers "Susceptibility Test Powders, Antimicrobial", a Class II medical device regulated under 21 CFR 866.1640. Submissions are reviewed by the Microbiology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- JTT
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- 510(k)
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K983310 | Accumed Intl | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN | Dec 17, 1998 |
| K935805 | Pasco Laboratories | PASCO MIC AND MIC/ID PANELS | Jun 13, 1994 |
| K895362 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST | Dec 1, 1989 |
| K880574 | Merck, Sharp And Dohme | MODIFIED IMIPENEM SUSCEPTIBILITY POWDER | May 4, 1988 |
| K872081 | Miles Pharmaceuticals | CIPRO (TM) DIAGNOSTIC POWDER | Jun 15, 1987 |
| K864442 | Merck, Sharp And Dohme | NORFLOXACIN SUSCEPTIBILITY POWDER | Dec 11, 1986 |
| K855106 | Bd Becton Dickinson Vacutainer Systems Preanalytic | IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 | Mar 6, 1986 |
| K855071 | Merck, Sharp And Dohme | IMIPENEM SUSCEPTIBILITY POWDER | Mar 6, 1986 |
| K855207 | Difco Laboratories | IMIPENEM 10 MCG SENSITIVITY DISCS | Mar 6, 1986 |
| K860031 | Organon Teknika | GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK | Mar 6, 1986 |
| K830758 | Miles Laboratories | AZLIN AZLOCILIN SODIUM-DIAG. REAGENT | May 25, 1983 |
| K822866 | Lilly Research Laboratories | MOXALACTAM | Dec 28, 1982 |
| K822329 | Bd Becton Dickinson Vacutainer Systems Preanalytic | ANTITUBERCULOUS DRUGS (SIRE) | Sep 2, 1982 |
| K820578 | Miles Pharmaceuticals | MEZLIN DIAGNOSTIC REAGENT | May 12, 1982 |