Uni-Gold H. Pylori
FDA 510(k) K991697 · Trinity Biotech, Plc
510(k) numberK991697
Submission
- Device name
- Uni-Gold H. Pylori
- Applicant
- Trinity Biotech, Plc
Los Angeles, CA, US - Received
- May 18, 1999
- Decision date
- December 21, 1999
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K172254 | Lyme B. burgdorferi (IgM) MarStripe TestLSR · Traditional | 10/23/2017SE |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe TestLSR · Traditional | 02/01/2017SE |
| K120001 | Unigold GiardiaMHI · Traditional | 03/01/2013SE |
| K121565 | Uni-Gold CryptosporidiumMHJ · Traditional | 02/08/2013SE |
| K083896 | Destiny Max Coagulation AnalyzerJPA · Traditional | 07/02/2009SE |
| K033059 | Herpes Group IggLGC · Traditional | 11/26/2003SE |
| K014233 | Captiam Syphilis-G AssayLIP · Special | 01/24/2002SE |
| K011709 | Uni-Gold Strep a Test KitGTZ · Traditional | 11/08/2001SE |
| K001525 | Captia Syphilis-G Elisa Test SystemLIP · Traditional | 11/29/2000SE |
| K982373 | Uni-Gold Strep a Test KitGTY · Traditional | 02/11/1999SE |
Questions and answers
When was Uni-Gold H. Pylori cleared by the FDA?
Uni-Gold H. Pylori (K991697) received a 510(k) decision of Substantially Equivalent on December 21, 1999, 217 days after the submission was received.
What is the product code of K991697?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.