Kronus Market Development Associates, Inc.
Star, ID, US
Kronus Market Development Associates, Inc. appears in FDA device records in Star, ID. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Kronus Market Development Associates, Inc. between 2003 and 2014. The busiest year on record is 2008, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 2 |
| 2008 | 3 |
| 2012 | 2 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| DEN140001 | ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT | PHF | Unknown | |
| K121046 | STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT | PCG | Substantially Equivalent | |
| K111956 | KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT | PAF | Substantially Equivalent | |
| K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT | NST | Substantially Equivalent | |
| K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | JZO | Substantially Equivalent | |
| K073590 | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT | OIF | Substantially Equivalent | |
| K072135 | KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT | NWG | Substantially Equivalent | |
| K070183 | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT | OCN | Substantially Equivalent | |
| K051061 | KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT | NWG | Substantially Equivalent | |
| K042248 | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT | NST | Substantially Equivalent | |
| K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT | JZO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- PCG21-Hydroxylase Antibody (21-Ohab)
- NSTAutoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
- NWGAutoantibodies, Glutamic Acid Decarboxylase (Gad)
- OCNInsulin Autoantibody Kit
- JZOSystem, Test, Thyroid Autoantibody
- OIFTyrosine Phosphatase (Ia-2) Autoantibody Assay
- PAFVoltage Gated Calcium Channel (Vgcc) Antibody Assay
- PHFZinc Transporter 8 Auto-Antibody
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain