Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

37 results for "Quidel Corporation"
1–24 of 37
Cleared Mar 22, 2024
QuickVue COVID-19 Test
K231795 · QYT
Quidel Corporation
Microbiology · 276d
Cleared Dec 20, 2023
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
K232286 · PGI
Quidel Corporation
Microbiology · 141d
Cleared Dec 13, 2023
Sofia 2 SARS Antigen+ FIA
K233688 · QVF
Quidel Corporation
Microbiology · 26d
Cleared Mar 10, 2023
Lyra RSV+hMPV Assay
K230349 · OEM
Quidel Corporation
Microbiology · 29d
Not Cleared Mar 08, 2023
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
DEN220039 · QVF
Quidel Corporation
Microbiology · 265d
Cleared Mar 03, 2023
Lyra Influenza A+B Assay
K230236 · OZE
Quidel Corporation
Microbiology · 32d
Cleared Nov 23, 2021
Sofia 2 Campylobacter FIA
K211342 · LQP
Quidel Corporation
Microbiology · 204d
Cleared Aug 30, 2018
Sofia 2 Lyme FIA, Sofia Lyme Control Set
K173496 · LSR
Quidel Corporation
Microbiology · 290d
Cleared Jul 15, 2018
Solana Bordetella Complete Assay
K181029 · OZZ
Quidel Corporation
Microbiology · 88d
Cleared Feb 28, 2018
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
K173691 · LSR
Quidel Corporation
Microbiology · 89d
Cleared Feb 13, 2018
QuickVue Influenza A+B
K180288 · PSZ
Quidel Corporation
Microbiology · 12d
Cleared Dec 21, 2017
Solana GBS Assay
K173250 · NJR
Quidel Corporation
Microbiology · 72d
Cleared Dec 21, 2017
Sofia Strep A+ FIA, Sofia 2 Analyzer
K171976 · GTY
Quidel Corporation
Microbiology · 174d
Cleared Oct 20, 2017
Sofia Lyme FIA, Sofia Lyme Control Set
K163713 · LSR
Quidel Corporation
Microbiology · 294d
Cleared Oct 16, 2017
Solana RSV+hMPV Assay
K171974 · OCC
Quidel Corporation
Microbiology · 108d
Cleared May 11, 2017
Solana C. difficile Assay
K170491 · OZN
Quidel Corporation
Microbiology · 83d
Cleared Apr 14, 2017
Sofia Influenza A+B FIA on Sofia 2
K162438 · PSZ
Quidel Corporation
Microbiology · 226d
Cleared Feb 22, 2017
Sofia RSV FIA on Sofia 2 analyzer
K162911 · GQG
Quidel Corporation
Microbiology · 128d
Cleared Nov 28, 2016
Solana HSV 1+2/VZV Assay
K162451 · PGI
Quidel Corporation
Microbiology · 88d
Cleared Oct 25, 2016
Solana Strep Complete Assay
K162274 · PGX
Quidel Corporation
Microbiology · 74d
Cleared Sep 27, 2016
Solana Influenza A+B Assay
K161814 · OCC
Quidel Corporation
Microbiology · 88d
Cleared Aug 15, 2016
Solana Trichomonas Assay
K161182 · OUY
Quidel Corporation
Microbiology · 110d
Cleared Jan 12, 2016
Sofia Influenza A+B FIA
K153012 · PSZ
Quidel Corporation
Microbiology · 90d
Cleared Jun 23, 2015
Solana GAS Assay, Solana instrument
K150868 · PGX
Quidel Corporation
Microbiology · 83d