Quanta Lite H.Pylori Iga Elisa
FDA 510(k) K024334 · Inova Diagnostics, Inc.
510(k) numberK024334
Submission
- Device name
- Quanta Lite H.Pylori Iga Elisa
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- December 26, 2002
- Decision date
- March 27, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetLYR · Traditional | DiaSorin, Inc. | 08/31/2018SE |
| K181400 | H. Pylori ChekLYR · Traditional | Techlab, Inc. | 08/21/2018SE |
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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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| K200230 | Aptiva Celiac Disease IgG ReagentMVM · Traditional | 08/26/2021SE |
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| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL · Traditional | 12/11/2020SE |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional | 04/17/2019SE |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | 10/16/2018SE |
| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | 06/25/2018SE |
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Questions and answers
When was Quanta Lite H.Pylori Iga Elisa cleared by the FDA?
Quanta Lite H.Pylori Iga Elisa (K024334) received a 510(k) decision of Substantially Equivalent on March 27, 2003, 91 days after the submission was received.
What is the product code of K024334?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.