Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Biokit, S.A. — Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

159 daysmedian FDA review time

302 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243575	ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITE	Biokit, S.A.	2025-02-12	85	0
K233605	ADVIA Centaur EBV-EBNA IgG	Biokit, S.A.	2024-08-07	272	0
K233606	ADVIA Centaur EBV-VCA IgM	Biokit, S.A.	2024-08-07	272	0
K213987	ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITE	Biokit, S.A.	2023-09-20	639	0
K214068	Quantia IgE	Biokit, S.A.	2023-02-21	421	0
K181333	ADVIA Centaur Herpes-1 IgG	Biokit, S.A.	2018-08-23	94	0
K181334	ADVIA Centaur Herpes-2 IgG	Biokit, S.A.	2018-08-23	94	1
K152185	ARCHITECT SHBG	Biokit, S.A.	2016-02-11	190	0
K132400	LP(A) CALIBRATORS, AND LP(A) CONTROLS	Biokit, S.A.	2013-12-19	140	0
K123947	ARCHITECT IVANCOMYCIN	Biokit, S.A.	2013-08-29	251	0
K110619	ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CA	Biokit, S.A.	2011-11-23	265	1
K082953	ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODEL	Biokit, S.A.	2008-12-22	80	0
K082141	ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CON	Biokit, S.A.	2008-09-03	35	0
K072036	ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CAL	Biokit, S.A.	2008-03-19	238	1
K072078	QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307	Biokit, S.A.	2007-12-19	142	0
K063232	ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROL	Biokit, S.A.	2007-06-19	237	2
K070810	ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)	Biokit, S.A.	2007-06-08	74	0
K060818	ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, A	Biokit, S.A.	2007-01-23	302	1
K060027	ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM	Biokit, S.A.	2006-01-26	22	0
K050493	QUANTIA IGE	Biokit, S.A.	2005-08-16	169	0
K050613	QUANTIA BETA-2 MICROGLOBULIN	Biokit, S.A.	2005-08-16	159	0
K050596	QUANTIA A1-AT	Biokit, S.A.	2005-05-13	66	0
K050487	QUANTIA LA(A)	Biokit, S.A.	2005-04-26	60	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda