Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LKQ — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
109 daysmedian FDA review time
316 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100433 | IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULI | Siemens Healthcare Diagnostics | 2010-05-13 | 86 | 0 |
| K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-08-22 | 17 | 0 |
| K933549 | VIDAS CMV IGM ASSAY | Biomerieux Vitek, Inc. | 1994-08-02 | 376 | 1 |
| K922580 | BARTELS CYTOMEGALOVIRUS IGM EIA | Baxter Diagnostics, Inc. | 1993-04-08 | 316 | 0 |
| K914789 | ELISA CMV IGM | Sclavo, Inc. | 1992-03-04 | 133 | 0 |
| K913080 | OPUS(R) ANTI CMV-M | Pb Diagnostics, Inc. | 1991-10-28 | 109 | 0 |
| K900743 | CMV-IGM IFA TEST SYSTEM | Zeus Scientific, Inc. | 1990-04-26 | 69 | 0 |
| K893465 | CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | Immuno Concepts, Inc. | 1989-07-25 | 83 | 0 |
| K893466 | CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) | Immuno Concepts, Inc. | 1989-07-14 | 72 | 0 |
| K872881 | ABBOTT CMV-M EIA KIT | Abbott Laboratories | 1988-05-13 | 296 | 0 |
| K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 | Clinical Sciences, Inc. | 1988-01-11 | 168 | 0 |
| K871832 | CMV IGM MICROASSAY | Diamedix Corp. | 1987-08-07 | 88 | 0 |
| K863798 | FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES | Whittaker Bioproducts, Inc. | 1987-04-14 | 197 | 0 |
| K861363 | ENZYGNOST ANTI-CMV IGM TEST | Behring Diagnostics, Inc. | 1986-07-21 | 102 | 0 |
| K860450 | THE CMV-IGM TEST | Microbiological Research Corp. | 1986-05-13 | 98 | 0 |
| K853889 | CORDIA CMV-M | Cordis Corp. | 1986-04-21 | 214 | 0 |
| K854839 | CYTOMEGELISA M TEST KIT | Whittaker Bioproducts, Inc. | 1986-02-04 | 62 | 0 |
| K831711 | CMV IGM TEST | Gull Laboratories, Inc. | 1983-10-27 | 153 | 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