POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS— 510(k) K110413
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K110413 for POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS, Substantially Equivalent on 2011-05-11. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code CDD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Brea, CA, US
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More clearances from Beckman Coulter, Inc.
view allRecalls naming K110413
K-number listed on FDA's recall record- Z-0117-2022 — Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
- Z-0046-2018 — Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110413.
Data sourced from openFDA. This site is unofficial and independent of the FDA.