RAPIDPOINT 500 BLOOD GAS ANALYER
FDA 510(k) clearance K113216 · decided 2012-05-03
Clearance details
- K-number
- K113216
- Device name
- RAPIDPOINT 500 BLOOD GAS ANALYER
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2011-11-01
- Decision date
- 2012-05-03
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- KHP
- Device class
- 1
- Regulation number
- 862.1450
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Norowood, MA, US
- Third-party review
- No
- Expedited review
- No
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| Dimension FPSA Flex reagent cartridge (P020027/S041) | Siemens Healthcare Diagnostics | 2025-02-24 |
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