|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
roche combitrol and autotrol plus b multi analyte control
|
BIONOSTICS, INC.
|
K032453 |
08/28/2003
|
medica easyqc blood gas/electrolyte control
|
BIONOSTICS, INC.
|
K021930 |
06/25/2002
|
combitrol ts multi analyte control, levels 1,2,3, autotrol ts multi analyte control, levels 1,2,3
|
BIONOSTICS, INC.
|
K012431 |
08/28/2001
|
oxyhemoglobin control for co-oximetry
|
BIONOSTICS, INC.
|
K980178 |
02/12/1998
|
trademark blood gas/electrolyte/glucose, lactate, bun and creatinine control
|
BIONOSTICS, INC.
|
K972868 |
08/28/1997
|
rna medical's equil plus with glucose control
|
BIONOSTICS, INC.
|
K950399 |
02/22/1995
|
blood gads, electrolyte, glucose, latate and bun quality control product
|
BIONOSTICS, INC.
|
K943754 |
09/14/1994
|
chality control material (assayed & unassayed)
|
BIONOSTICS, INC.
|
K913133 |
09/27/1991
|
control for ph,blood gases,eletrolytes,glucose
|
BIONOSTICS, INC.
|
K911755 |
05/22/1991
|
multi-function blood gas control
|
BIONOSTICS, INC.
|
K880447 |
05/27/1988
|
|