|
Device |
separator, automated, blood cell and plasma, therapeutic |
Product Code | LKN |
Device Class |
Unclassified
|
Premarket Reviews |
Manufacturer | Decision |
CARIDIANBCT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FENWAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FRESENIUS KABI AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FRESENIUS KABI USA LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO BCT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K131744 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SING ...
|
2. K132429 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYST ...
|
3. K141938 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCH ...
|
TERUMO BCT, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K131744 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SING ...
|
2. K132429 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYST ...
|
3. K141938 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCH ...
|
TERUMO BCT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
1. K131744 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SING ...
|
2. K132429 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYST ...
|
3. K141938 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCH ...
|
TERUMO BCT, INC.. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
1. K131744 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SING ...
|
2. K132429 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYST ...
|
3. K141938 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCH ...
|
|
|
|
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