Solana Bordetella Complete Assay— 510(k) K181029
Substantially EquivalentQuidel Corporation
FDA 510(k) clearance K181029 for Solana Bordetella Complete Assay, Substantially Equivalent on 2018-07-15. Applicant: Quidel Corporation. Device class: 2.
Clearance details
- Applicant
- Quidel Corporation
- Product code
- Code OZZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Athens, OH, US
Recent devices under product code OZZ
view all- K243753 — cobas liat Bordetella panel nucleic acid test
- K183223 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- K173498 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- K163626 — ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
- K170284 — Great Basin Bordetella Direct Test
More clearances from Quidel Corporation
view all- K231795 — QuickVue COVID-19 Test
- K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- K233688 — Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
- K230349 — Lyra RSV+hMPV Assay
- DEN220039 — Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
Recalls naming K181029
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 K181029.
Data sourced from openFDA. This site is unofficial and independent of the FDA.