NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
FDA 510(k) clearance K073537 · decided 2008-06-27
Clearance details
- K-number
- K073537
- Device name
- NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
- Applicant
- Siemens Medical Solutions Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2007-12-17
- Decision date
- 2008-06-27
- Days to decision
- 193 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 |
|---|---|---|
| The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gase recall (Z-1962-2015) | Siemens Healthcare Diagnostics, Inc | 2015-07-02 |
| RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab recall (Z-1254-2015) | Siemens Healthcare Diagnostics Inc | 2015-03-06 |
| RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab recall (Z-1255-2015) | Siemens Healthcare Diagnostics Inc | 2015-03-06 |
| Siemens RAPIDLab 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The recall (Z-0107-2014) | Siemens Healthcare Diagnostics Inc | 2013-10-29 |
| Siemens RAPIDLab 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The recall (Z-0108-2014) | Siemens Healthcare Diagnostics Inc | 2013-10-29 |