|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
3m integrated cycler (110v) & (220v)
|
FOCUS DIAGNOSTICS, INC.
|
K102314 |
10/29/2010
|
3test glucose monitoring system
|
NEUERO ENGINEERING INC.
|
K050224 |
07/13/2005
|
3test supreme glucose monitoring system
|
NEUERO ENGINEERING INC.
|
K072905 |
04/18/2008
|
6-acetylmorphine enzyme immunoassay with 6-acetylmorphine calibrators and controls
|
Lin-Zhi International, Inc.
|
K101195 |
07/06/2010
|
a-lyte® integrated multisensor (imt na k cl)
|
Siemens Healthcare Diagnostics Inc.
|
K222438 |
07/25/2023
|
a/c enzymatic vitamin b6 assay
|
ANTICANCER INC
|
K111260 |
07/26/2012
|
a/c portable enzymatic homocysteine assay
|
ANTICANCER INC
|
K080851 |
10/10/2008
|
a1at genotyping test
|
Progenika Biopharma S.A., a Grifols Company
|
K171868 |
11/11/2017
|
a1at genotyping test
|
Progenika Biopharma S.A., A Grifols Company
|
K192858 |
11/05/2019
|
a1at genotyping test
|
Progenika Biopharma S.A., a Grifols company
|
K211115 |
05/13/2021
|