Data / Medical devices / United States / Kronus, Inc.
Kronus, Inc.: FDA-registered device maker in Star, ID, United States, 14 510(k) clearances
Kronus, Inc. is registered with the FDA (registration 2025560) in Star, ID, United States. It lists 9 device types. The FDA files 14 510(k) clearances under its listings, the newest dated August 24, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2025560
- Address
- 170 S. Seneca Springs Way Suite 105, Star, ID, United States, 83669
- Owner or operator
- KRONUS, INC. (2025560)
- Roles
- Repackager or relabeler
- First device listed
- April 5, 2006
- Registered through
- 2027
- Brand names listed
- KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay, KRONUS GLUTAMIC ACID DEC, KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit, KRONUS TRAb CT, KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 21-Hydroxylase Antibody (21-Ohab) | PCG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Aquaporin-4 Autoantibody | PNI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking | NST | 2 | Repackager or relabeler | accessdata.fda.gov |
| Autoantibodies, Glutamic Acid Decarboxylase (Gad) | NWG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Insulin Autoantibody Kit | OCN | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Test, Thyroid Autoantibody | JZO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tyrosine Phosphatase (Ia-2) Autoantibody Assay | OIF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Voltage Gated Calcium Channel (Vgcc) Antibody Assay | PAF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Zinc Transporter 8 Auto-Antibody | PHF | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 24, 2023 | K220085 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | OIF | Substantially Equivalent | Kronus, Inc. | accessdata.fda.gov |
| November 23, 2018 | K180607 | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit | PCG | Substantially Equivalent | Kronus, Inc. | accessdata.fda.gov |
| January 19, 2018 | K171731 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | OIF | Substantially Equivalent | Kronus, Inc. | accessdata.fda.gov |
| July 22, 2016 | K161951 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | PNI | Substantially Equivalent | Kronus, Inc. | accessdata.fda.gov |
| August 20, 2014 | DEN140001 | ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT | PHF | Unknown | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
| May 30, 2012 | K111956 | KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT | PAF | Substantially Equivalent | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
| June 17, 2008 | K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT | NST | Substantially Equivalent | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
| May 22, 2008 | K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | JZO | Substantially Equivalent | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
| April 10, 2008 | K073590 | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT | OIF | Substantially Equivalent | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
| November 7, 2007 | K072135 | KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT | NWG | Substantially Equivalent | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
| July 13, 2007 | K070183 | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT | OCN | Substantially Equivalent | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
| November 4, 2005 | K051061 | KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT | NWG | Substantially Equivalent | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
| December 17, 2004 | K042248 | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT | NST | Substantially Equivalent | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
| September 10, 2003 | K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT | JZO | Substantially Equivalent | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.