Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LQP — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
75 daysmedian FDA review time
204 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210976 | Curian Campy | Meridian Bioscience, Inc. | 2021-12-23 | 266 | 0 |
| K211342 | Sofia 2 Campylobacter FIA | Quidel Corporation | 2021-11-23 | 204 | 0 |
| K191442 | Campylobacter Chek | Techlab, Inc. | 2019-06-20 | 21 | 0 |
| K191456 | Campylobacter Quik Chek | Techlab, Inc. | 2019-06-20 | 20 | 0 |
| K173219 | CAMPYLOBACTER CHEK | Techlab, Inc. | 2018-01-22 | 111 | 0 |
| K173217 | CAMPYLOBACTER QUIK CHEK | Techlab, Inc. | 2018-01-22 | 111 | 0 |
| K090700 | IMMUNOCARD STAT CAMPY, MODEL 751530 | Meridian Bioscience, Inc. | 2009-05-28 | 72 | 0 |
| K083464 | PREMIER CAMPY, MODEL 618096 | Meridian Bioscience, Inc. | 2009-01-30 | 67 | 0 |
| K982315 | PROSPECT CAMPYLOBACTER MICROPLATE ASSAY | Alexon - Trend, Inc. | 1998-11-18 | 140 | 1 |
| K880389 | MERITEC(TM)-CAMPY (JCL) | Meridian Diagnostics, Inc. | 1988-04-12 | 75 | 0 |
| K864027 | BBL CAMPYSLIDE(TM) TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-12-11 | 57 | 0 |
| K862814 | COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI | Institute Virion , Ltd. | 1986-09-30 | 68 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda