FDA 510(k) Applications Submitted by Joan Guixe
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K181334 |
05/21/2018 |
ADVIA Centaur Herpes-2 IgG |
Biokit, S.A. |
| K060027 |
01/04/2006 |
ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) |
BIOKIT S.A. |
| K050487 |
02/25/2005 |
QUANTIA LA(A) |
BIOKIT S.A. |
| K050493 |
02/28/2005 |
QUANTIA IGE |
BIOKIT S.A. |
| K110619 |
03/03/2011 |
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS |
BIOKIT S.A. |
| K050596 |
03/08/2005 |
QUANTIA A1-AT |
BIOKIT S.A. |
| K050613 |
03/10/2005 |
QUANTIA BETA-2 MICROGLOBULIN |
BIOKIT S.A. |
| K070810 |
03/26/2007 |
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) |
BIOKIT S.A. |
| K060818 |
03/27/2006 |
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 |
BIOKIT S.A. |
| K181333 |
05/21/2018 |
ADVIA Centaur Herpes-1 IgG |
Biokit, S.A. |
| K072036 |
07/25/2007 |
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 |
BIOKIT S.A. |
| K072078 |
07/30/2007 |
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 |
BIOKIT S.A. |
| K082141 |
07/30/2008 |
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 |
BIOKIT S.A. |
| K132400 |
08/01/2013 |
LP(A) CALIBRATORS, AND LP(A) CONTROLS |
BIOKIT S.A. |
| K082953 |
10/03/2008 |
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 |
BIOKIT S.A. |
| K063232 |
10/25/2006 |
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 |
BIOKIT S.A. |
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