Meritec(Tm)-Campy (JCL)
FDA 510(k) K880389 · Meridian Diagnostics, Inc.
510(k) numberK880389
Submission
- Device name
- Meritec(Tm)-Campy (JCL)
- Applicant
- Meridian Diagnostics, Inc.
Cincinnati, OH, US - Received
- January 28, 1988
- Decision date
- April 12, 1988
- 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 |
| K864027 | BBL Campyslide(Tm) TestLQP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/11/1986SE |
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| K982711 | Premier GiardiaMHI · Traditional | 11/25/1998SE |
| K980076 | Premier Platinum HpsaLYR · Traditional | 05/12/1998SE |
| K980077 | Para-Pak SpinconLKS · Traditional | 04/02/1998SE |
| K971585 | Immunocard Stat! RotavirusLIQ · Traditional | 08/20/1997SE |
Questions and answers
When was Meritec(Tm)-Campy (JCL) cleared by the FDA?
Meritec(Tm)-Campy (JCL) (K880389) received a 510(k) decision of Substantially Equivalent on April 12, 1988, 75 days after the submission was received.
What is the product code of K880389?
The FDA product code is LQP – Campylobacter Spp., a Class I (low risk) device regulated under 21 CFR 866.3110.