FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iQ200 Series
K Number: K252580
·
Decision Sep 10, 2025
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
14
Applicant Total
270
Review Days
26
Basic Information
- Device Name
- iQ200 Series
- K Number
- K252580
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter, Inc.
- Date Received
- August 15, 2025
- Decision Date
- September 10, 2025
- Product Code
- LKM
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKM | Counter, Urine Particle | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKM), ordered by most recent decision date.
AUTION EYE AI-4510 Urine Particle Analysis System
FDA 510(k)
FDA Class 2
·Hematology
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
FDA 510(k)
FDA Class 2
·Hematology
cobas u 701 microscopy analyzer
FDA 510(k)
FDA Class 2
·Hematology
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
FDA 510(k)
FDA Class 2
·Hematology
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Beckman Coulter, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252169 | Access BNP II | Mar 24, 2026 | Substantially Equivalent |
| K254059 | Access anti-HBc IgM | Mar 13, 2026 | Substantially Equivalent |
| K253687 | Access anti-HBc Total | Feb 19, 2026 | Substantially Equivalent |
| K251995 | Access anti-HAV IgM | Jan 27, 2026 | Substantially Equivalent |
| K250588 | Access Rubella IgG | Nov 17, 2025 | Substantially Equivalent |
| K243846 | Access anti-HAV | Sep 9, 2025 | Substantially Equivalent |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | Aug 20, 2025 | Substantially Equivalent |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | Aug 15, 2025 | Substantially Equivalent |
| K243483 | Access hsTnI | Aug 1, 2025 | Substantially Equivalent |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | Jul 18, 2025 | Substantially Equivalent |