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

Counter, Urine Particle

21 CFR 864.5200 / Hematology
FDA source (opens on fda.gov)

LKM is the FDA product code for Counter, Urine Particle, a class II device type, regulated under 21 CFR 864.5200. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
LKM
Device name
Counter, Urine Particle
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
15
Ingested recalls
6

Clearances, product code LKM

By decision year
15 clearances under product code LKM with a decision year between 1982 and 2025, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LKM by decision year
YearClearances
19821
19961
20001
20011
20021
20061
20071
20081
20091
20101
20181
20201
20211
20241
20251

Applicants with the most clearances

Product code LKM
Applicants holding the most 510(k) clearances under product code LKM
ApplicantClearances
Sysmex America, Inc.5
Siemens Healthcare Diagnostics Inc.2
Intl. Remote Imaging Systems2
Sysmex Corporation2
Arkray, Inc.1
Eko Scann AB1
Iris International, Inc.1
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code