|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
meter trax trilevel, low level, mid level, high level trilevel minipak
|
BIO-RAD LABORATORIES, INC.
|
K042336 |
10/14/2004
|
lyphochek whole blood control, models 561, 562, 563
|
BIO-RAD LABORATORIES, INC.
|
K022041 |
07/16/2002
|
lyphochek assayed chemistry control
|
BIO-RAD LABORATORIES, INC.
|
K040273 |
03/04/2004
|
liquichek urine chemistry control
|
BIO-RAD LABORATORIES, INC.
|
K020817 |
04/12/2002
|
liquichek torch plus igm control
|
BIO-RAD LABORATORIES, INC.
|
K040822 |
05/19/2004
|
liquichek specialty immunoassay control
|
BIO-RAD LABORATORIES, INC.
|
K043108 |
12/07/2004
|
liquichek pediatric control, level 1; liquichek pediatric contol, level 2; liquichek pediatric control, bilevel minipak
|
BIO-RAD LABORATORIES, INC.
|
K130963 |
05/06/2013
|
liquichek cardiac marker control lt
|
BIO-RAD LABORATORIES, INC.
|
K040277 |
03/10/2004
|
bioplex 2200 torc igg
|
BIO-RAD LABORATORIES, INC.
|
K120572 |
03/26/2012
|
bioplex 2200 system torc igg kit, calibrator set and control set
|
BIO-RAD LABORATORIES, INC.
|
K080008 |
02/23/2009
|