Premier Campy, Model 618096
FDA 510(k) K083464 · Meridian Bioscience, Inc.
510(k) numberK083464
Submission
- Device name
- Premier Campy, Model 618096
- Applicant
- Meridian Bioscience, Inc.
Cincinnati, OH, US - Received
- November 24, 2008
- Decision date
- January 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K864027 | BBL Campyslide(Tm) TestLQP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/11/1986SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K243922 | RevogeneOOI · Traditional | 03/20/2025SE |
| K230901 | Premier HpSA Flex (619096)LYR · Traditional | 07/03/2023SE |
| K222829 | Curian® Shiga ToxinGMZ · Traditional | 04/17/2023SE |
| K222779 | RevogeneOOI · Special | 01/26/2023SE |
| K220480 | RevogeneOOI · Traditional | 07/11/2022SE |
| K210976 | Curian CampyLQP · Traditional | 12/23/2021SE |
| K192817 | Curian HpSA, Curian AnalyzerLYR · Traditional | 03/13/2020SE |
| K182559 | PREMIER Platinum HpSA PLUSLYR · Traditional | 11/05/2018SE |
| K163273 | TRU LegionellaMJH · Special | 02/21/2017SE |
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct…OZX · Traditional | 06/13/2016SE |
Questions and answers
When was Premier Campy, Model 618096 cleared by the FDA?
Premier Campy, Model 618096 (K083464) received a 510(k) decision of Substantially Equivalent on January 30, 2009, 67 days after the submission was received.
What is the product code of K083464?
The FDA product code is LQP – Campylobacter Spp., a Class I (low risk) device regulated under 21 CFR 866.3110.