BAYER RAPIDPOINT 400 SYSTEM
FDA 510(k) clearance K002738 · decided 2000-12-19
Clearance details
- K-number
- K002738
- Device name
- BAYER RAPIDPOINT 400 SYSTEM
- Applicant
- Bayer Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-01
- Decision date
- 2000-12-19
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Medfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. recall (Z-2230-2025) | Siemens Healthcare Diagnostics Inc | 2025-07-31 |
| Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161 recall (Z-2912-2016) | 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 |
| Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended recall (Z-0102-2014) | Siemens Healthcare Diagnostics Inc | 2013-10-29 |
| RapidPoint 400 Analyzers for Blood Gas, Electrolytes and metabolites Software Versions pri recall (Z-1019-2010) | Siemens Healthcare Diagnostics Inc | 2010-03-08 |
| RapidPoint 405 System Analyzers The RP405 is capable of testing all of the analytes listed recall (Z-1020-2010) | Siemens Healthcare Diagnostics Inc | 2010-03-08 |