Atlas FDA

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

Diasorin Molecular, LLC — Predicate Candidate Screening

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

133 daysmedian FDA review time
431 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep ControlDiasorin Molecular, LLC2026-06-151330
K251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLC2025-12-231790
K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); SimplexaDiasorin Molecular, LLC2025-10-30910
DEN230092Simplexa C. auris Direct, Simplexa C. auris Positive ControlDiasorin Molecular, LLC2024-07-152000
K220963Simplexa COVID-19 & Flu A/B DirectDiasorin Molecular, LLC2023-03-173500
K202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV PDiasorin Molecular, LLC2022-11-057750
K212147Simplexa COVID-19 DirectDiasorin Molecular, LLC2022-09-134310
K201505Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSVDiasorin Molecular, LLC2020-08-22781
K192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC2019-11-26881
K190219Simplexa VZV Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC2019-05-13981
K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive ConDiasorin Molecular, LLC2018-12-19290
K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC2018-11-07580
K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive ConDiasorin Molecular, LLC2018-08-132730
K173798Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive ContrDiasorin Molecular, LLC2018-03-14900

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