FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SPECTRA OPTIA R APHERESIS SYSTEM
K Number: K103090
·
Decision Nov 19, 2010
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
26
Applicant Total
2
Review Days
31
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Basic Information
- Device Name
- SPECTRA OPTIA R APHERESIS SYSTEM
- K Number
- K103090
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Caridianbct, Inc..
- Date Received
- October 19, 2010
- Decision Date
- November 19, 2010
- Product Code
- LKN
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKN), ordered by most recent decision date.
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AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
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Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
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Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Caridianbct, Inc..
| K Number | Device Name | ||
|---|---|---|---|
| K113480 | SPECTRA OPTIA APHERESIS SYSTEM | Jan 20, 2012 | Substantially Equivalent |