Sofia 2 Campylobacter FIA
FDA 510(k) K211342 · Quidel Corporation
510(k) numberK211342
Submission
- Device name
- Sofia 2 Campylobacter FIA
- Applicant
- Quidel Corporation
San Diego, CA, US - Received
- May 3, 2021
- Decision date
- November 23, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LQP – Campylobacter Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Specialty
- Microbiology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210976 | Curian CampyLQP · Traditional | Meridian Bioscience, Inc. | 12/23/2021SE |
| K191456 | Campylobacter Quik ChekLQP · Special | Techlab, Inc. | 06/20/2019SE |
| K191442 | Campylobacter ChekLQP · Special | Techlab, Inc. | 06/20/2019SE |
| K173219 | Campylobacter ChekLQP · Traditional | Techlab, Inc. | 01/22/2018SE |
| K173217 | Campylobacter Quik ChekLQP · Traditional | Techlab, Inc. | 01/22/2018SE |
| K090700 | Immunocard Stat Campy, Model 751530LQP · Traditional | Meridian Bioscience, Inc. | 05/28/2009SE |
| K083464 | Premier Campy, Model 618096LQP · Traditional | Meridian Bioscience, Inc. | 01/30/2009SE |
| K982315 | Prospect Campylobacter Microplate AssayLQP · Traditional | Alexon - Trend, Inc. | 11/18/1998SE |
| K880389 | Meritec(Tm)-Campy (JCL)LQP · Traditional | Meridian Diagnostics, Inc. | 04/12/1988SE |
| K864027 | BBL Campyslide(Tm) TestLQP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/11/1986SE |
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Questions and answers
When was Sofia 2 Campylobacter FIA cleared by the FDA?
Sofia 2 Campylobacter FIA (K211342) received a 510(k) decision of Substantially Equivalent on November 23, 2021, 204 days after the submission was received.
What is the product code of K211342?
The FDA product code is LQP – Campylobacter Spp., a Class I (low risk) device regulated under 21 CFR 866.3110.