Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mercia Diagnostics , Ltd. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
231 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K915479 | CAPTIA CMV-TA | Mercia Diagnostics , Ltd. | 1992-05-04 | 150 | 0 |
| K904524 | CAPTIA(R) SYPHILIS M, MODIFICATION | Mercia Diagnostics , Ltd. | 1990-12-26 | 90 | 1 |
| K900654 | MODIFIED CAPTIA(R) SYPHILIS-M | Mercia Diagnostics , Ltd. | 1990-03-08 | 27 | 0 |
| K896295 | CAPTIA(R) CMV-M | Mercia Diagnostics , Ltd. | 1990-03-06 | 126 | 0 |
| K896194 | CAPTIA(R) CMV-G | Mercia Diagnostics , Ltd. | 1990-03-06 | 132 | 0 |
| K900655 | MODIFIED CAPTIA(R) TOXO-M | Mercia Diagnostics , Ltd. | 1990-03-06 | 25 | 0 |
| K883924 | CAPTIA(R) RUBELLA-G | Mercia Diagnostics , Ltd. | 1989-08-15 | 333 | 0 |
| K885300 | CAPTIA(R) RUBELLA-M | Mercia Diagnostics , Ltd. | 1989-08-15 | 231 | 0 |
| K892802 | SUPER DUO | Mercia Diagnostics , Ltd. | 1989-06-13 | 57 | 0 |
| K881425 | CAPTIA(R) SYPHILIS-G | Mercia Diagnostics , Ltd. | 1988-08-04 | 121 | 0 |
| K880918 | CAPTIA TOXO-G | Mercia Diagnostics , Ltd. | 1988-08-01 | 150 | 0 |
| K875138 | TRICHOMATE(R) SUPER | Mercia Diagnostics , Ltd. | 1988-05-13 | 150 | 0 |
| K873740 | ROTASCREEN EIA | Mercia Diagnostics , Ltd. | 1987-11-27 | 73 | 0 |
| K872568 | ROTASCREEN | Mercia Diagnostics , Ltd. | 1987-09-14 | 77 | 0 |
| K871548 | CAPTIA(R) SYPHILIS-M | Mercia Diagnostics , Ltd. | 1987-08-07 | 109 | 0 |
| K871746 | CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY | Mercia Diagnostics , Ltd. | 1987-07-31 | 87 | 0 |
| K863499 | CANDIDATE(R) SUPER | Mercia Diagnostics , Ltd. | 1987-03-19 | 191 | 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