RAPIDPOINT 405 NEONATAL BILIRUBIN
FDA 510(k) clearance K110277 · decided 2011-08-15
Clearance details
- K-number
- K110277
- Device name
- RAPIDPOINT 405 NEONATAL BILIRUBIN
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2011-01-31
- Decision date
- 2011-08-15
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- MQM
- Device class
- 1
- Regulation number
- 862.1113
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Norowood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313 recall (Z-2913-2016) | Siemens Healthcare Diagnostics Inc | 2016-09-30 |
| RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 1069 recall (Z-2479-2015) | Siemens Healthcare Diagnostics Inc | 2015-08-28 |
| RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, recall (Z-1252-2015) | Siemens Healthcare Diagnostics Inc | 2015-03-06 |
| Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are intende recall (Z-0103-2014) | Siemens Healthcare Diagnostics Inc | 2013-10-29 |
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