CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
FDA 510(k) clearance K880353 · decided 1988-06-15
Clearance details
- K-number
- K880353
- Device name
- CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
- Applicant
- Ciba Corning Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-26
- Decision date
- 1988-06-15
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- GKR
- Device class
- 2
- Regulation number
- 864.5620
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- East Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.