Ubi Magiwel(Tm) Helicobacter Pylori Igg
FDA 510(k) K924689 · United Biotech, Inc.
510(k) numberK924689
Submission
- Device name
- Ubi Magiwel(Tm) Helicobacter Pylori Igg
- Applicant
- United Biotech, Inc.
Mountain View, CA, US - Received
- September 17, 1992
- Decision date
- August 10, 1993
- 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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|---|---|---|---|
| K232892 | Hp Detect Stool Antigen ELISALYR · Traditional | Biomerica, Inc. | 12/15/2023SE |
| K230901 | Premier HpSA Flex (619096)LYR · Traditional | Meridian Bioscience, Inc. | 07/03/2023SE |
| K192817 | Curian HpSA, Curian AnalyzerLYR · Traditional | Meridian Bioscience, Inc. | 03/13/2020SE |
| K183573 | Vstrip H. pylori Antigen Rapid TestLYR · Traditional | Panion & BF Biotech, Inc. | 03/14/2019SE |
| K182559 | PREMIER Platinum HpSA PLUSLYR · Traditional | Meridian Bioscience, Inc. | 11/05/2018SE |
| 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 |
| K181379 | H. Pylori Quik ChekLYR · Traditional | Techlab, Inc. | 08/21/2018SE |
| 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 |
More from Meridian Bioscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981573 | Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia QuantitatveJFH · Traditional | 09/15/1998SE |
| K973154 | Ubi Magiwel Marijuana MetabolitesLDJ · Traditional | 07/22/1998SE |
| K973692 | Ubi Magiwel C-Reactive Protein(Crp) QuantitativeDCK · Traditional | 02/09/1998SE |
| K973156 | Ubi Magiwel Cocaine MetabolitesDJG · Traditional | 10/28/1997SE |
| K973155 | Ubi Magiwel Opiate MetabolitesDJG · Traditional | 10/28/1997SE |
| K973153 | Ubi Magiwel Amphetamine MetabolitesDJG · Traditional | 10/28/1997SE |
| K962211 | Ubi Magiwel Thyroxine (T4) QuantitativeKLI · Traditional | 07/08/1996SE |
| K961236 | Ubi Magiwel TRIIODOTHYRONINE(T3) QuantitativeCDP · Traditional | 05/30/1996SE |
| K951993 | Ubi Magiwel Ferritin QuantitativeDBF · Traditional | 07/05/1995SE |
| K905473 | Ubi Magiwel Cortisol QuantitativeCGR · Traditional | 01/31/1991SE |
Questions and answers
When was Ubi Magiwel(Tm) Helicobacter Pylori Igg cleared by the FDA?
Ubi Magiwel(Tm) Helicobacter Pylori Igg (K924689) received a 510(k) decision of Substantially Equivalent on August 10, 1993, 327 days after the submission was received.
What is the product code of K924689?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.