|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
ausam total albumin assay
|
AUSAM BIOTECTHNOLOGIES INC
|
K013643 |
08/14/2003
|
aml haircheck-dt (cocaine)
|
QUEST DIAGNOSTICS, INC.
|
K023626 |
09/29/2003
|
combi-screen, models 10sl and 11sl
|
ANALYTICON BIOTECHNOLOGIES AG
|
K023885 |
10/21/2003
|
dri methadone metabolite enzyme immunoassay
|
MICROGENICS CORP.
|
K023617 |
08/27/2003
|
glucoleader value
|
HMD BIOMEDICAL, INC.
|
K023279 |
08/04/2003
|
i-stat kaolin act test
|
I-STAT CORPORATION
|
K023582 |
09/08/2003
|
lifesign home drug test (ecstasy/met), status stik met & mdma, accusign stik met & mdma, accustik met & mdma
|
PRINCETON BIOMEDITECH CORP.
|
K023837 |
09/15/2003
|
randox rx daytona
|
RANDOX LABORATORIES, LTD.
|
K024014 |
12/04/2003
|
visualine methadone dipstriptest
|
SUN BIOMEDICAL LABORATORIES, INC.
|
K023856 |
08/25/2003
|
wiener lab. chagatest elisa recomninante v.3.0, model 96 tests cat. nr. 1203254
|
WIENER LABORATORIES S.A.I.C.
|
K023889 |
02/11/2004
|