Biokit, S.A.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K243575	ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls	MYF	2025-02-12	View
510(k)	K233606	ADVIA Centaur EBV-VCA IgM	LSE	2024-08-07	View
510(k)	K233605	ADVIA Centaur EBV-EBNA IgG	LLM	2024-08-07	View
510(k)	K213987	ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls	MXJ	2023-09-20	View
510(k)	K214068	Quantia IgE	DGC	2023-02-21	View
510(k)	K181333	ADVIA Centaur Herpes-1 IgG	MXJ	2018-08-23	View
510(k)	K181334	ADVIA Centaur Herpes-2 IgG	MYF	2018-08-23	View
510(k)	K152185	ARCHITECT SHBG	CDZ	2016-02-11	View
510(k)	K132400	LP(A) CALIBRATORS, AND LP(A) CONTROLS	JIT	2013-12-19	View
510(k)	K123947	ARCHITECT IVANCOMYCIN	LEH	2013-08-29	View
510(k)	K110619	ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS	MRG	2011-11-23	View
510(k)	K082953	ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01	KXT	2008-12-22	View
510(k)	K082141	ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10	JIT	2008-09-03	View
510(k)	K072036	ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01	LEH	2008-03-19	View
510(k)	K072078	QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307	JZG	2007-12-19	View
510(k)	K063232	ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01	CEW	2007-06-19	View
510(k)	K070810	ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)	LGS	2007-06-08	View
510(k)	K060818	ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01	CDZ	2007-01-23	View
510(k)	K060027	ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)	JJX	2006-01-26	View
510(k)	K050493	QUANTIA IGE	DGC	2005-08-16	View