CEA CONTROL PLASMA— 510(k) K812658
Substantially EquivalentPacific Hemostasis
FDA 510(k) clearance K812658 for CEA CONTROL PLASMA, Substantially Equivalent on 1981-09-29. Applicant: Pacific Hemostasis. Device class: 2.
Clearance details
- Applicant
- Pacific Hemostasis
- Product code
- Code DHX
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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