Biokit, S.A. is one of 56 FDA 510(k) medical device manufacturers from Spain in the dataset, ranked by real submission volume.
Biokit, S.A. - FDA 510(k) Cleared Devices
Recent clearances: ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls, ADVIA Centaur EBV-EBNA IgG, ADVIA Centaur EBV-VCA IgM
23
Total
23
Cleared
0
Denied
Biokit, S.A. has 23 FDA 510(k) cleared medical devices. Based in Barcelona, ES.
Latest FDA clearance: Feb 2025. Active since 2005.
Browse the FDA 510(k) cleared devices submitted by Biokit, S.A. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Biokit, S.A.
23 devices
Cleared
Feb 12, 2025
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG...
Microbiology
85d
Cleared
Aug 07, 2024
ADVIA Centaur EBV-EBNA IgG
Microbiology
272d
Cleared
Aug 07, 2024
ADVIA Centaur EBV-VCA IgM
Microbiology
272d
Cleared
Sep 20, 2023
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG...
Microbiology
639d
Cleared
Feb 21, 2023
Quantia IgE
Immunology
421d
Cleared
Aug 23, 2018
ADVIA Centaur Herpes-1 IgG
Microbiology
94d
Cleared
Aug 23, 2018
ADVIA Centaur Herpes-2 IgG
Microbiology
94d
Cleared
Feb 11, 2016
ARCHITECT SHBG
Chemistry
190d
Cleared
Dec 19, 2013
LP(A) CALIBRATORS, AND LP(A) CONTROLS
Chemistry
140d
Cleared
Aug 29, 2013
ARCHITECT IVANCOMYCIN
Toxicology
251d
Cleared
Nov 23, 2011
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS,...
Chemistry
265d
Cleared
Dec 22, 2008
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND...
Toxicology
80d
Cleared
Sep 03, 2008
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS...
Chemistry
35d
Cleared
Mar 19, 2008
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS:...
Toxicology
238d
Cleared
Dec 19, 2007
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
Immunology
142d
Cleared
Jun 19, 2007
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM,...
Chemistry
237d
Cleared
Jun 08, 2007
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
Toxicology
74d
Cleared
Jan 23, 2007
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG...
Chemistry
302d
Cleared
Jan 26, 2006
ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
Chemistry
22d
Cleared
Aug 16, 2005
QUANTIA IGE
Immunology
169d
Cleared
Aug 16, 2005
QUANTIA BETA-2 MICROGLOBULIN
Immunology
159d
Cleared
May 13, 2005
QUANTIA A1-AT
Immunology
66d
Cleared
Apr 26, 2005
QUANTIA LA(A)
Chemistry
60d