Product code LQP
- Device name
- Campylobacter Spp.
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3110
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210976 | Curian Campy | Meridian Bioscience, Inc. | 2021-12-23 |
| K211342 | Sofia 2 Campylobacter FIA | Quidel Corporation | 2021-11-23 |
| K191442 | Campylobacter Chek | Techlab, Inc. | 2019-06-20 |
| K191456 | Campylobacter Quik Chek | Techlab, Inc. | 2019-06-20 |
| K173217 | CAMPYLOBACTER QUIK CHEK | Techlab, Inc. | 2018-01-22 |
| K173219 | CAMPYLOBACTER CHEK | Techlab, Inc. | 2018-01-22 |
| K090700 | IMMUNOCARD STAT CAMPY, MODEL 751530 | Meridian Bioscience, Inc. | 2009-05-28 |
| K083464 | PREMIER CAMPY, MODEL 618096 | Meridian Bioscience, Inc. | 2009-01-30 |
| K982315 | PROSPECT CAMPYLOBACTER MICROPLATE ASSAY | Alexon - Trend, Inc. | 1998-11-18 |
| K880389 | MERITEC(TM)-CAMPY (JCL) | Meridian Diagnostics, Inc. | 1988-04-12 |
| K864027 | BBL CAMPYSLIDE(TM) TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-12-11 |
| K862814 | COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI | Institute Virion , Ltd. | 1986-09-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30014613338772 | Sofia | QUIDEL CARDIOVASCULAR INC. | 2025-11-18 |
| 50014613338776 | Sofia | QUIDEL CARDIOVASCULAR INC. | 2025-11-18 |
| 05032384519583 | ProSpecT Campylobacter Microplate Assay 96 Tests | OXOID LIMITED | 2024-06-20 |
| 00840733102387 | Curian Campy | MERIDIAN BIOSCIENCE, INC. | 2023-03-23 |
| 00840733101717 | PREMIER CAMPY | MERIDIAN BIOSCIENCE, INC. | 2020-09-01 |
| 00857031002486 | CAMPYLOBACTER CHEK | TECHLAB, INC. | 2019-08-06 |
| 00857031002578 | QuickVue TLI Campylobacter Test | TECHLAB, INC. | 2019-05-30 |
| 00857031002462 | CAMPYLOBACTER CHEK | TECHLAB, INC. | 2019-05-29 |
| 00857031002479 | CAMPYLOBACTER QUIK CHEK | TECHLAB, INC. | 2019-05-29 |
| 00857031002455 | CAMPYLOBACTER QUIK CHEK | TECHLAB, INC. | 2019-04-12 |
| 00840733101373 | ImmunoCard STAT! CAMPY | MERIDIAN BIOSCIENCE, INC. | 2018-08-06 |
| 00813545026288 | CAMPY (jcl) Latex 50 Test Kit | SCIMEDX CORPORATION | 2016-09-21 |