CEA CONTROL PLASMA
FDA 510(k) clearance K812658 · decided 1981-09-29
Clearance details
- K-number
- K812658
- Device name
- CEA CONTROL PLASMA
- Applicant
- Pacific Hemostasis
- Decision
- Substantially Equivalent
- Date received
- 1981-09-18
- Decision date
- 1981-09-29
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- DHX
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.