Quickvue One-Step Helicobactor Pylori Test
FDA 510(k) K952517 · Quidel Corp.
510(k) numberK952517
Submission
- Device name
- Quickvue One-Step Helicobactor Pylori Test
- Applicant
- Quidel Corp.
San Diego, CA, US - Received
- May 31, 1995
- Decision date
- February 6, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYR – Helicobacter Pylori
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Specialty
- Microbiology
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| K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetLYR · Traditional | DiaSorin, Inc. | 07/22/2016SE |
| K153661 | ImmunoCard STAT! HpSALYR · Traditional | Meridian Bioscience, Inc. | 03/14/2016SE |
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| K211342 | Sofia 2 Campylobacter FIALQP · Traditional | 11/23/2021SE |
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Questions and answers
When was Quickvue One-Step Helicobactor Pylori Test cleared by the FDA?
Quickvue One-Step Helicobactor Pylori Test (K952517) received a 510(k) decision of Substantially Equivalent on February 6, 1996, 251 days after the submission was received.
What is the product code of K952517?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.