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Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Ex…
FDA 510(k)U (US FDA 510(k))
510(k) K132429
Identifiers
- 510(k) Number
- K132429 FDA 510(k)
- FDA Product Code
- LKN FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Ex… by Terumo BCT, Inc.. — U — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132429 | U | Active |
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Manufacturer
- Manufacturer
- Terumo BCT, Inc..
- FDA Applicant
- Terumobct, Inc.
Sources (1)
- FDA 510(k) K132429 24 fields · synced Jun 18, 2026