JTT · Class II · 21 CFR 866.1640

FDA Product Code JTT: Susceptibility Test Powders, Antimicrobial

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Miles Laboratories, Inc. and Difco Laboratories, Inc..

14
Total
14
Cleared
75d
Avg days
1982
Since

FDA 510(k) Cleared Susceptibility Test Powders, Antimicrobial Devices (Product Code JTT)

14 devices
1–14 of 14
Cleared Jun 13, 1994
PASCO MIC AND MIC/ID PANELS
K935805
Pasco Laboratories, Inc.
Microbiology · 193d
Cleared Dec 01, 1989
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
K895362
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 94d
Cleared Mar 06, 1986
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
K855106
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 73d
Cleared Mar 06, 1986
IMIPENEM 10 MCG SENSITIVITY DISCS
K855207
Difco Laboratories, Inc.
Microbiology · 66d
Cleared Mar 06, 1986
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
K860031
Organon Teknika Corp.
Microbiology · 59d
Cleared May 25, 1983
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT
K830758
Miles Laboratories, Inc.
Microbiology · 76d
Cleared Sep 02, 1982
ANTITUBERCULOUS DRUGS (SIRE)
K822329
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 30d

About Product Code JTT - Regulatory Context