Product code JTT— Microbiology
ANTITUBERCULOUS DRUGS (SIRE)
- Classification name
- Susceptibility Test Powders, Antimicrobial
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Total cleared
- 14
- First cleared
- Most recent
Market context for product code JTT
FDA has cleared devices under product code JTT between 1982 and 1998, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1998
- 1994
- 1989
- 1988
- 1987
- 1986
- 1983
- 1982
Top applicants under product code JTT
Recent clearances under product code JTT
- K983310 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
- K935805 — PASCO MIC AND MIC/ID PANELS
- K895362 — BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
- K880574 — MODIFIED IMIPENEM SUSCEPTIBILITY POWDER
- K872081 — CIPRO (TM) DIAGNOSTIC POWDER
- K864442 — NORFLOXACIN SUSCEPTIBILITY POWDER
- K855071 — IMIPENEM SUSCEPTIBILITY POWDER
- K855106 — IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
- K855207 — IMIPENEM 10 MCG SENSITIVITY DISCS
- K860031 — GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
- K830758 — AZLIN AZLOCILIN SODIUM-DIAG. REAGENT
- K822866 — MOXALACTAM
- K822329 — ANTITUBERCULOUS DRUGS (SIRE)
- K820578 — MEZLIN DIAGNOSTIC REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.