iQ200 System, iChemVELOCITY Automated Urine Chemistry System— 510(k) K210127
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K210127 for iQ200 System, iChemVELOCITY Automated Urine Chemistry System, Substantially Equivalent on 2021-07-02. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Product code LKM
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code LKM
view allMore clearances from Beckman Coulter, Inc.
view allRecalls naming K210127
K-number listed on FDA's recall record- Z-0160-2027 — DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
- Z-0161-2027 — IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B48999, C10683
- Z-1596-2023 — iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
- Z-1597-2023 — DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
- Z-1598-2023 — DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
- Z-1599-2023 — UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210127.
Data sourced from openFDA. This site is unofficial and independent of the FDA.