Panels › Hematology › Product code LKM · Class 2
Counter, Urine Particle
Regulation 864.5200
0510(k)s in 12 months (15 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in LKM
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter, Inc. | 2 | 5 |
| Sysmex America, Inc. | 5 | 1 |
| Intl. Remote Imaging Systems | 2 | 0 |
| Sysmex Corp. | 2 | 0 |
| Arkray, Inc. | 1 | 0 |
| Eko Scann AB | 1 | 0 |
| Iris International, Inc. | 1 | 0 |
| Roche Diagnostics | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2024 | Beckman Coulter, Inc. iQ Waste Well Adapter, Part Number: 700-3393 Open, Classified |
LKM | K022774 |
| Jan 25, 2024 | Beckman Coulter, Inc. REV 2 Flowcell Capsule Spare, Part Number: C04154 Open, Classified |
LKM | K022774 |
| Jan 25, 2024 | Beckman Coulter, Inc. iQ200 Series Urine Microscopy Analyzers, Part Numbers:
a) 700-3320,
b) 700-3370,
c) 700-3345,
d) 700-3347,
e) C10683,
f) 700-3375,
g) 700-3325,
h) C10684 Open, Classified |
LKM | K022774 |
| Jan 25, 2024 | Beckman Coulter, Inc. Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947 Open, Classified |
LKM | K022774 |
| Oct 28, 2019 | Beckman Coulter Inc. iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10 Terminated |
LKM | K022774 |
| Feb 10, 2014 | Sysmex America, Inc. The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so Terminated |
LKM | K080887 |
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