BAYER RAPIDPOINT 405 SYSTEM— 510(k) K020616
Substantially EquivalentBayer Diagnostics Corp.
FDA 510(k) clearance K020616 for BAYER RAPIDPOINT 405 SYSTEM, Substantially Equivalent on 2002-07-17. Applicant: Bayer Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Diagnostics Corp.
- Product code
- Code GKR
- Device class
- Class 2
- Regulation
- 21 CFR 864.5620
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
Recent devices under product code GKR
view allMore clearances from Bayer Diagnostics Corp.
view allRecalls naming K020616
K-number listed on FDA's recall record- Z-2927-2018 — RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample.
- Z-2928-2018 — RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
- Z-2479-2015 — RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020616.
Data sourced from openFDA. This site is unofficial and independent of the FDA.