Hm-Cap Eia Test (Modification)
FDA 510(k) K955085 · Schiff & Co.
510(k) numberK955085
Submission
- Device name
- Hm-Cap Eia Test (Modification)
- Applicant
- Schiff & Co.
West Cadwell, NJ, US - Received
- October 26, 1995
- Decision date
- February 9, 1996
- 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
Other 510(k)s with product code LYR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K990511 | X-Tip Intraosseous PerforatorDZM · Traditional | 04/27/1999SE |
| K982136 | Jostra Venous Hardshell Cardiotomic Reservoir VHK 4200DTN · Traditional | 03/24/1999SE |
| K981629 | Nutrisafe Enteral Feeding TubeFPD · Traditional | 02/04/1999SE |
| K981630 | Vygon Double Lumen Umbilical CatheterFOS · Traditional | 10/01/1998SE |
| K974141 | Plus Reusable ResuscitatorBTM · Traditional | 05/21/1998SE |
| K954448 | Viotec V-2200 Ultraviolet Germicidal Air Purification SystemFRA · Traditional | 10/28/1996SE |
| K944159 | Hm-Cap Eia KitLYR · Traditional | 07/18/1995SE |
| K943521 | Viotec 1400 Series Ultraviolet Germicidal FixtureFRA · Traditional | 02/14/1995SE |
| K896684 | Kemble Liquid Handling System DispenserJQW · Traditional | 04/16/1990SE |
| K894617 | Olympus Pk-Tp System Reactive ControlGMI · Traditional | 10/31/1989SE |
Questions and answers
When was Hm-Cap Eia Test (Modification) cleared by the FDA?
Hm-Cap Eia Test (Modification) (K955085) received a 510(k) decision of Substantially Equivalent on February 9, 1996, 106 days after the submission was received.
What is the product code of K955085?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.