Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kronus Market Development Associates, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
258 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| DEN140001 | ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT | Kronus Market Development Associates, Inc. | 2014-08-20 | 65 | 0 |
| K121046 | STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT | Kronus Market Development Associates, Inc. | 2012-12-20 | 258 | 0 |
| K111956 | KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASS | Kronus Market Development Associates, Inc. | 2012-05-30 | 324 | 0 |
| K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) | Kronus Market Development Associates, Inc. | 2008-06-17 | 112 | 0 |
| K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | Kronus Market Development Associates, Inc. | 2008-05-22 | 120 | 0 |
| K073590 | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT | Kronus Market Development Associates, Inc. | 2008-04-10 | 112 | 0 |
| K072135 | KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT | Kronus Market Development Associates, Inc. | 2007-11-07 | 97 | 0 |
| K070183 | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT | Kronus Market Development Associates, Inc. | 2007-07-13 | 175 | 0 |
| K051061 | KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT | Kronus Market Development Associates, Inc. | 2005-11-04 | 192 | 0 |
| K042248 | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSA | Kronus Market Development Associates, Inc. | 2004-12-17 | 120 | 0 |
| K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT | Kronus Market Development Associates, Inc. | 2003-09-10 | 61 | 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