|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
lp(a) calibrators, and lp(a) controls
|
BIOKIT S.A.
|
K132400 |
12/19/2013
|
architect 25-oh vitamin d 100t, vitamin d 500t, vitamin d calibrators, vitamin d controls
|
BIOKIT S.A.
|
K110619 |
11/23/2011
|
architect c-peptide calibrators, and architect c-peptide controls, models 3l53-01, 3l53-10
|
BIOKIT S.A.
|
K082141 |
09/03/2008
|
architect intact pth reagents, calibrators (a-f) and controls (low, medium, high), models 8k25-20, 8k25-25, 8k25-01
|
BIOKIT S.A.
|
K063232 |
06/19/2007
|
architect shbg reagent kit, architect shbg calibrator kit, and architect shbg control kit with models, 8k26-25, 8k26-01
|
BIOKIT S.A.
|
K060818 |
01/23/2007
|
architect dhea-s calibrators (a-f) and controls (low, medium and high)
|
BIOKIT S.A.
|
K060027 |
01/26/2006
|
quantia beta-2 microglobulin
|
BIOKIT S.A.
|
K050613 |
08/16/2005
|
quantia ige
|
BIOKIT S.A.
|
K050493 |
08/16/2005
|
quantia a1-at
|
BIOKIT S.A.
|
K050596 |
05/13/2005
|
quantia la(a)
|
BIOKIT S.A.
|
K050487 |
04/26/2005
|
|