Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack— 510(k) K192376
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K192376 for Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack, Substantially Equivalent on 2019-11-26. Applicant: Diasorin Molecular, LLC. Device class: 2.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code PGI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3309
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Recent devices under product code PGI
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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
Recalls naming K192376
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 K192376.
Data sourced from openFDA. This site is unofficial and independent of the FDA.