Medical Device Manufacturer · ES , Barcelona

Biokit, S.A.

23 submissions · 23 cleared · Since 2005
23
Total
23
Cleared
0
Denied

Biokit, S.A. — FDA 510(k) Submissions

Biokit, S.A. has submitted 23 FDA 510(k) premarket notifications since 2005, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Vancomycin, Calibrator, Secondary, Ige, Antigen, Antiserum, Control, Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1, Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
K243575 · MYF Enzyme Linked... · Microbiology
Feb 2025 85d
ADVIA Centaur EBV-EBNA IgG
K233605 · LLM Test, Antigen, Nuclear,... · Microbiology
Aug 2024 272d
ADVIA Centaur EBV-VCA IgM
K233606 · LSE Epstein-barr Virus, Other · Microbiology
Aug 2024 272d
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
K213987 · MXJ Enzyme Linked... · Microbiology
Sep 2023 639d
Quantia IgE
K214068 · DGC Ige, Antigen, Antiserum,... · Immunology
Feb 2023 421d
ADVIA Centaur Herpes-1 IgG
K181333 · MXJ Enzyme Linked... · Microbiology
Aug 2018 94d
ADVIA Centaur Herpes-2 IgG
K181334 · MYF Enzyme Linked... · Microbiology
Aug 2018 94d
ARCHITECT SHBG
K152185 · CDZ Radioimmunoassay,... · Chemistry
Feb 2016 190d
LP(A) CALIBRATORS, AND LP(A) CONTROLS
K132400 · JIT Calibrator, Secondary · Chemistry
Dec 2013 140d
ARCHITECT IVANCOMYCIN
K123947 · LEH Radioimmunoassay, Vancomycin · Toxicology
Aug 2013 251d
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
K110619 · MRG System, Test, Vitamin D · Chemistry
Nov 2011 265d
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
K082953 · KXT Enzyme Immunoassay, Digoxin · Toxicology
Dec 2008 80d
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10
K082141 · JIT Calibrator, Secondary · Chemistry
Sep 2008 35d
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
K072036 · LEH Radioimmunoassay, Vancomycin · Toxicology
Mar 2008 238d
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
K072078 · JZG System, Test,... · Immunology
Dec 2007 142d
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
K063232 · CEW Radioimmunoassay,... · Chemistry
Jun 2007 237d
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
K070810 · LGS Fluorescence Polarization... · Toxicology
Jun 2007 74d
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01
K060818 · CDZ Radioimmunoassay,... · Chemistry
Jan 2007 302d
ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
K060027 · JJX Single (specified)... · Chemistry
Jan 2006 22d
QUANTIA IGE
K050493 · DGC Ige, Antigen, Antiserum,... · Immunology
Aug 2005 169d
QUANTIA BETA-2 MICROGLOBULIN
K050613 · JZG System, Test,... · Immunology
Aug 2005 159d
QUANTIA A1-AT
K050596 · DEM Alpha-1-antitrypsin,... · Immunology
May 2005 66d
QUANTIA LA(A)
K050487 · DFC Lipoprotein, Low-density,... · Chemistry
Apr 2005 60d
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