510(k) K110277 ยท MQM Bilirubin (Total And Unbound) In The Neonate Test System
RAPIDPOINT 405 NEONATAL BILIRUBIN
| Applicant | Siemens Healthcare Diagnostics, Norowood MA, US |
| Decision | Substantially Equivalent, Aug 15, 2011 |
| Received | Jan 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2016 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 405 Measurement Cartridge
Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469 Terminated |
JFS | None listed |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 405 Blood Gas Analyzer nBili
Siemens Material Number (SMN):
10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Terminated |
CHL | 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 |
| Mar 6, 2015 | Siemens Healthcare Diagnostics Inc RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784.
These systems are intended for near-pa Terminated |
MQM | None listed |
| Oct 29, 2013 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 405 system blood gas analyzer
Product PUsage:
These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and he Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.