ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL— 510(k) K082638
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K082638 for ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL, Substantially Equivalent on 2009-02-26. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code KLI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code KLI
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K082638
K-number listed on FDA's recall record- Z-0215-2019 — STREAMLAB CORE UNIT / LYNX WITH IOM
- Z-0216-2019 — STREAMLAB - REFRIGERATED STORAGE MODULE 9000
- Z-0217-2019 — STREAMLAB - REFRIGERATED STORAGE MODULE 15000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082638.
Data sourced from openFDA. This site is unofficial and independent of the FDA.