|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
hemosil readiplastin
|
Instrumentation Laboratory Co.
|
K213426 |
08/16/2022
|
hemosil recombiplastin 2g (8 ml vial)
|
INSTRUMENTATION LABORATORY CO.
|
K132722 |
01/22/2014
|
hemosil readiplas tin
|
INSTRUMENTATION LABORATORY CO.
|
K122584 |
03/24/2013
|
hemosil recombiplastin 2g
|
INSTRUMENTATION LABORATORY CO.
|
K070005 |
08/15/2007
|
hemosil pt-fibrinogen hs plus
|
INSTRUMENTATION LABORATORY CO.
|
K060931 |
05/02/2006
|
hemosil recombiplastin
|
INSTRUMENTATION LABORATORY CO.
|
K043184 |
12/22/2004
|
hemosil recombi plastin
|
INSTRUMENTATION LABORATORY CO.
|
K012768 |
09/18/2001
|
il test pt-fibrinogen recombinant
|
INSTRUMENTATION LABORATORY CO.
|
K981479 |
07/07/1998
|
assess(tm) high abnormal control
|
INSTRUMENTATION LABORATORY CO.
|
K931118 |
03/30/1994
|
assess(tm) low abnormal control
|
INSTRUMENTATION LABORATORY CO.
|
K931117 |
03/30/1994
|