Simplexa VZV Direct, Simplexa VZV Positive Control Pack— 510(k) K190219
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K190219 for Simplexa VZV Direct, Simplexa VZV Positive Control Pack, Substantially Equivalent on 2019-05-13. Applicant: Diasorin Molecular, LLC. Device class: 2.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code PLO
- Device class
- Class 2
- Regulation
- 21 CFR 866.3970
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Recent devices under product code PLO
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 PLO
product code PLO- Death
- 5
- Total
- 5
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 K190219
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 K190219.
Data sourced from openFDA. This site is unofficial and independent of the FDA.