iQ200 Series— 510(k) K252580
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K252580 for iQ200 Series, Substantially Equivalent on 2025-09-10. 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
- Special
- Location
- Miami, FL, US
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More clearances from Beckman Coulter, Inc.
view allRecalls naming K252580
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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K252580.
Data sourced from openFDA. This site is unofficial and independent of the FDA.