LTW · Class II · 21 CFR 866.1640

FDA Product Code LTW: Susceptibility Test Cards, Antimicrobial

Leading manufacturers include Austin Biological Laboratories, Analytical Products, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

16
Total
16
Cleared
102d
Avg days
1984
Since

FDA 510(k) Cleared Susceptibility Test Cards, Antimicrobial Devices (Product Code LTW)

16 devices
1–16 of 16
Cleared Sep 16, 1985
PRECEPT CEFTRIAXONE
K853273
Austin Biological Laboratories
Microbiology · 42d
Cleared Sep 16, 1985
PRECEPT CEFOPERAZONE
K853596
Austin Biological Laboratories
Microbiology · 20d
Cleared Sep 16, 1985
PRECEPT TM CARBENICILLIN
K853685
Austin Biological Laboratories
Microbiology · 178d
Cleared Sep 16, 1985
PRECEPT METHICILLIN
K853772
Austin Biological Laboratories
Microbiology · 147d
Cleared Sep 13, 1985
PRECEPT KANAMYCIN
K853684
Austin Biological Laboratories
Microbiology · 175d
Cleared Sep 13, 1985
PRECEPT TM AMIKACIN
K853686
Austin Biological Laboratories
Microbiology · 175d
Cleared Sep 13, 1985
PRECEPT NETILMICIN 32-13
K853687
Austin Biological Laboratories
Microbiology · 196d
Cleared Sep 13, 1985
PRECEPT TM TOBRAMYCIN
K853688
Austin Biological Laboratories
Microbiology · 196d
Cleared Sep 13, 1985
PRECEPT TM MOXALACTAM
K853689
Austin Biological Laboratories
Microbiology · 196d
Cleared Aug 29, 1985
PRECEPT ERYTHROMYCIN
K853053
Austin Biological Laboratories
Microbiology · 41d
Cleared Aug 29, 1985
PRECEPT AVGMENTIN
K853263
Austin Biological Laboratories
Microbiology · 24d
Cleared Mar 26, 1985
API UNISCEPT KB
K850347
Analytical Products, Inc.
Microbiology · 57d
Cleared Dec 14, 1984
API UNISCEPT MIC 100UL
K844159
Analytical Products, Inc.
Microbiology · 51d
Cleared Nov 07, 1984
SCEPTOR BETA-LACTAM PLUS MIC PANEL
K844231
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 8d
Cleared Oct 24, 1984
API UNISCEPT KB
K843733
Analytical Products, Inc.
Microbiology · 30d

About Product Code LTW - Regulatory Context