Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack— 510(k) K201505
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K201505 for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack, Substantially Equivalent on 2020-08-22. Applicant: Diasorin Molecular, LLC. Device class: 2.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Recent devices under product code OCC
view allMore clearances from Diasorin Molecular, LLC
view all- K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit
- K251978 — LIAISON NES FLU A/B, RSV & COVID-19
- K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
- DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- K220963 — Simplexa COVID-19 & Flu A/B Direct
Adverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K201505
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201505.
Data sourced from openFDA. This site is unofficial and independent of the FDA.