510(k) K982315
- Device
- PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
- Applicant
- ALEXON - TREND, INC.
- 510(k) number
- K982315
- Product code
- LQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-11-18
- Date received
- 1998-07-01
- Regulation
- 866.3110
- Classification name
- Campylobacter Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEN HOOD
- Address
- 14000 Unity St. NW Ramsey MN US 55303 55303
FDA Registration Numbers#
- 3012516456
- 3003750284
- 3005360469
- 3033507883
- 3002792284
- 3009935129
- 8010096
- 2182595
- 3021090658
- 2024674
- 3014684020
- 3033751096
- 9610140
- 2020808
- 1524213
- 1122855
- 3026664926
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LQP #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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