510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LIEClass II

Reagent/Device, Inoculum Calibration

21 CFR 866.1640 / Microbiology
FDA source (opens on fda.gov)

LIE is the FDA product code for Reagent/Device, Inoculum Calibration, a class II device type, regulated under 21 CFR 866.1640. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LIE
Device name
Reagent/Device, Inoculum Calibration
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
7
Ingested recalls
2

Clearances, product code LIE

By decision year
7 clearances under product code LIE with a decision year between 1982 and 2023, 2011 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LIE by decision year
YearClearances
19821
19891
19911
19941
20112
20231

Applicants with the most clearances

Product code LIE
Applicants holding the most 510(k) clearances under product code LIE
ApplicantClearances
Trek Diagnostic Systems, Ltd.2
3M Company1
Siemens Healthcare Diagnostics Inc.1
Difco Laboratories, Inc.1
Radiometer America, Inc1
Scientific Device Laboratory, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code