510(k) K020616 ยท GKR System, Hemoglobin, Automated
BAYER RAPIDPOINT 405 SYSTEM
| Applicant | Bayer Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Jul 17, 2002 |
| Received | Feb 25, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020616
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2018 | Siemens Healthcare Diagnostics, Inc. 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-q Terminated |
GKR | None listed |
| Jul 16, 2018 | Siemens Healthcare Diagnostics, Inc. 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, elec Terminated |
GKR | None listed |
| Aug 28, 2015 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Blood Gas Analyzer,
Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306
This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin de Terminated |
KHP | None listed |
| Oct 24, 2003 | Bayer Corp. Bayer Rapidpoint 405 Blood Gas Analyzer Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.