Complement-Fixation Test for Campylobacter Jejuni
FDA 510(k) K862814 · Institute Virion , Ltd.
510(k) numberK862814
Submission
- Device name
- Complement-Fixation Test for Campylobacter Jejuni
- Applicant
- Institute Virion , Ltd.
Zurich, Switzerland, CH - Received
- July 24, 1986
- Decision date
- September 30, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQP – Campylobacter Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Specialty
- Microbiology
Other 510(k)s with product code LQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210976 | Curian CampyLQP · Traditional | Meridian Bioscience, Inc. | 12/23/2021SE |
| K211342 | Sofia 2 Campylobacter FIALQP · Traditional | Quidel Corporation | 11/23/2021SE |
| K191456 | Campylobacter Quik ChekLQP · Special | Techlab, Inc. | 06/20/2019SE |
| K191442 | Campylobacter ChekLQP · Special | Techlab, Inc. | 06/20/2019SE |
| K173219 | Campylobacter ChekLQP · Traditional | Techlab, Inc. | 01/22/2018SE |
| K173217 | Campylobacter Quik ChekLQP · Traditional | Techlab, Inc. | 01/22/2018SE |
| K090700 | Immunocard Stat Campy, Model 751530LQP · Traditional | Meridian Bioscience, Inc. | 05/28/2009SE |
| K083464 | Premier Campy, Model 618096LQP · Traditional | Meridian Bioscience, Inc. | 01/30/2009SE |
| K982315 | Prospect Campylobacter Microplate AssayLQP · Traditional | Alexon - Trend, Inc. | 11/18/1998SE |
| K880389 | Meritec(Tm)-Campy (JCL)LQP · Traditional | Meridian Diagnostics, Inc. | 04/12/1988SE |
More from Meridian Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843676 | Varicella/Zoster VirusGQW · Traditional | 09/26/1985SE |
| K843673 | Respiratory Syncytial VirusGQG · Traditional | 09/26/1985SE |
| K843667 | Parainfluenza 3GQS · Traditional | 09/26/1985SE |
| K843665 | Parainfluenza 1GQS · Traditional | 09/26/1985SE |
| K843662 | Measles Virus RubeolaGRJ · Traditional | 09/26/1985SE |
| K843660 | In Fluenza B VirusGNX · Traditional | 09/26/1985SE |
| K843659 | Influenza A2 VirusGNX · Traditional | 09/26/1985SE |
| K843658 | H. Simplex VirusGQN · Traditional | 09/26/1985SE |
| K843657 | CytomegalovirusGQH · Traditional | 09/26/1985SE |
| K843649 | AdenovirusGOD · Traditional | 09/26/1985SE |
Questions and answers
When was Complement-Fixation Test for Campylobacter Jejuni cleared by the FDA?
Complement-Fixation Test for Campylobacter Jejuni (K862814) received a 510(k) decision of Substantially Equivalent on September 30, 1986, 68 days after the submission was received.
What is the product code of K862814?
The FDA product code is LQP – Campylobacter Spp., a Class I (low risk) device regulated under 21 CFR 866.3110.