Kronus Market Development Associates, Inc.: FDA clearances and approvals
Kronus Market Development Associates, Inc. has 10 FDA 510(k) clearances (first 2003, latest 2012), plus 1 De Novo decision, across 8 product codes in 1 review panel. Median 510(k) review time: 120 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 291 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | 2 | 2 |
| NST | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking | 2 | 2 |
| NWG | Autoantibodies, Glutamic Acid Decarboxylase (Gad) | 2 | 2 |
| OCN | Insulin Autoantibody Kit | 1 | 1 |
| OIF | Tyrosine Phosphatase (Ia-2) Autoantibody Assay | 1 | 1 |
| PAF | Voltage Gated Calcium Channel (Vgcc) Antibody Assay | 1 | 1 |
| PCG | 21-Hydroxylase Antibody (21-Ohab) | 1 | 1 |
| PHF | Zinc Transporter 8 Auto-Antibody | 1 | 0 |
Review panels
- Immunology (11)
Most recent Kronus Market Development Associates, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121046 | STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT | PCG | 2012-12-20 | 258 |
| K111956 | KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT | PAF | 2012-05-30 | 324 |
| K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT | NST | 2008-06-17 | 112 |
| K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | JZO | 2008-05-22 | 120 |
| K073590 | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT | OIF | 2008-04-10 | 112 |
| K072135 | KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT | NWG | 2007-11-07 | 97 |
| K070183 | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT | OCN | 2007-07-13 | 175 |
| K051061 | KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT | NWG | 2005-11-04 | 192 |
| K042248 | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT | NST | 2004-12-17 | 120 |
| K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT | JZO | 2003-09-10 | 61 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140001 | De Novo | Zinc Transporter 8 Auto-Antibody | 2014-08-20 |
Recalls
openFDA lists no recalls under a recalling firm named Kronus Market Development Associates, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Kronus Market Development Associates, Inc. have?
Kronus Market Development Associates, Inc. has 10 FDA 510(k) clearances (first 2003, latest 2012), plus 1 De Novo decision, across 8 product codes in 1 review panel.
How long does FDA take to clear Kronus Market Development Associates, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Kronus Market Development Associates, Inc.'s cleared 510(k)s is 120 days.
What devices does Kronus Market Development Associates, Inc. make?
Its most frequent FDA product codes are JZO (System, Test, Thyroid Autoantibody, 2); NST (Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking, 2); NWG (Autoantibodies, Glutamic Acid Decarboxylase (Gad), 2).
Has Kronus Market Development Associates, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kronus Market Development Associates, Inc. Related entities may recall under other names.
Next steps
- See all 10 Kronus Market Development Associates, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JZO, Kronus Market Development Associates, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.