DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE— 510(k) K043546
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K043546 for DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE, Substantially Equivalent on 2005-01-18. Applicant: Dade Behring, Inc.. Device class: 1.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code CDT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1705
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Newark, DE, US
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Recalls naming K043546
K-number listed on FDA's recall record- Z-2091-2023 — Aptio Automation Storage and Retrieval Module (SRM)
- Z-0193-2022 — Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043546.
Data sourced from openFDA. This site is unofficial and independent of the FDA.