LIE · Class II · 21 CFR 866.1640

FDA Product Code LIE: Reagent/device, Inoculum Calibration

Leading manufacturers include Beckman Coulter, Inc., 3M Company and Difco Laboratories, Inc..

7
Total
7
Cleared
127d
Avg days
1982
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Reagent/device, Inoculum Calibration Devices (Product Code LIE)

7 devices
1–7 of 7
Cleared Apr 05, 2023
MicroScan Prompt Inoculation System-D
K221493
Beckman Coulter, Inc.
Microbiology · 317d
Cleared Mar 29, 1994
SENSI-CAL AMCO AEPA-1
K935566
Radiometer America, Inc.
Microbiology · 131d
Cleared Jun 10, 1991
TURBIDOMETRIC STANDARD
K911059
Scientific Device Laboratory, Inc.
Microbiology · 91d
Cleared Feb 07, 1989
DIFCO DIRECTOR INOCULATION SYSTEM
K890339
Difco Laboratories, Inc.
Microbiology · 15d
Cleared Mar 15, 1982
PROMPT INOCULATION SYSTEM
K820299
3M Company
Microbiology · 39d

About Product Code LIE - Regulatory Context

510(k) Submission Activity

7 total 510(k) submissions under product code LIE since 1982, with 7 receiving FDA clearance (average review time: 127 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.