Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MCB — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
151 daysmedian FDA review time
312 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132010 | VIDAS C DIFFICILE GDH | Biomerieux S.A. | 2013-10-09 | 100 | 0 |
| K112048 | IMMUNOCARD C. DIFFICILE GDH | Meridian Bioscience, Inc. | 2011-12-16 | 151 | 0 |
| K110620 | PREMIER C. DIFFICILE GDH | Meridian Bioscience, Inc. | 2011-05-03 | 61 | 0 |
| K053572 | C. DIFF QUIK CHEK | Techlab, Inc. | 2006-04-26 | 125 | 0 |
| K974881 | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DI | Biosite Incorporated | 1998-03-20 | 80 | 1 |
| K955067 | CLEARVIEW C. DIFF A | Unipath , Ltd. | 1996-09-13 | 312 | 0 |
| K924062 | MERITEC C. DIFFICILE CONTROLS | Meridian Diagnostics, Inc. | 1992-10-19 | 68 | 0 |
| K904329 | CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1991-03-12 | 173 | 0 |
| K895915 | MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM | Meridian Diagnostics, Inc. | 1990-03-12 | 153 | 0 |
| K833447 | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- | Bartels Immunodiagnostic Supplies, Inc. | 1984-05-21 | 229 | 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