MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
FDA 510(k) clearance K122539 · decided 2013-04-19
Clearance details
- K-number
- K122539
- Device name
- MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2012-08-21
- Decision date
- 2013-04-19
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- 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
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| Dimension FPSA Flex reagent cartridge (P020027/S041) | Siemens Healthcare Diagnostics | 2025-02-24 |
| Dimension TPSA Flex reagent cartridge (P000021/S046) | Siemens Healthcare Diagnostics | 2025-02-24 |