Flexsure Hp,Controls for Flexsurehp,Flexpack Hp(Abbott Diagnostics)Andcontrols for Flexpack HP (Abbott Diagnostics)
FDA 510(k) K960183 · Smithkline Diagnostics, Inc.
510(k) numberK960183
Submission
- Device name
- Flexsure Hp,Controls for Flexsurehp,Flexpack Hp(Abbott Diagnostics)Andcontrols for Flexpack HP (Abbott Diagnostics)
- Applicant
- Smithkline Diagnostics, Inc.
San Jose, CA, US - Received
- January 16, 1996
- Decision date
- June 7, 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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|---|---|---|---|
| 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 |
|---|---|---|
| K961062 | Flexsure ObtKHE · Traditional | 11/06/1996SE |
| K934863 | Flexsure HPLYR · Traditional | 05/18/1994SE |
| K880499 | Hemoccult Sensitive TestKHE · Traditional | 05/23/1988SE |
| K875131 | (SKD) Cholesterol Test KitCHH · Traditional | 03/01/1988SE |
| K862849 | Hemoccult Wipe TestKHE · Traditional | 12/09/1986SE |
| K854723 | SKD Electrochemical System (Ecs)CEM · Traditional | 03/05/1986SE |
| K852841 | Rapid Direct Strep a Latex Agglutination TestGTZ · Traditional | 07/24/1985SE |
| K821884 | Gastroccult TMKHE · Traditional | 10/08/1982SE |
| K821674 | Spinchem Acid Phosphatase ReagentCKB · Traditional | 06/22/1982SE |
| K821184 | Spin Chem Reagents & StandardsJIY · Traditional | 05/24/1982SE |
Questions and answers
When was Flexsure Hp,Controls for Flexsurehp,Flexpack Hp(Abbott Diagnostics)Andcontrols for Flexpack HP (Abbott Diagnostics) cleared by the FDA?
Flexsure Hp,Controls for Flexsurehp,Flexpack Hp(Abbott Diagnostics)Andcontrols for Flexpack HP (Abbott Diagnostics) (K960183) received a 510(k) decision of Substantially Equivalent on June 7, 1996, 143 days after the submission was received.
What is the product code of K960183?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.