Company ยท US
Kronus Market Development Associates, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2014. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | 2 |
| NST | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking | 2 |
| NWG | Autoantibodies, Glutamic Acid Decarboxylase (Gad) | 2 |
| OCN | Insulin Autoantibody Kit | 1 |
| OIF | Tyrosine Phosphatase (Ia-2) Autoantibody Assay | 1 |
| PAF | Voltage Gated Calcium Channel (Vgcc) Antibody Assay | 1 |
| PCG | 21-Hydroxylase Antibody (21-Ohab) | 1 |
| PHF | Zinc Transporter 8 Auto-Antibody | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2014 | DEN140001 | ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT Kronus Market Development Associates, Inc. | PHF |
| Dec 20, 2012 | K121046 | STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT Kronus Market Development Associates, Inc. | PCG |
| May 30, 2012 | K111956 | KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT Kronus Market Development Associates, Inc. | PAF |
| Jun 17, 2008 | K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT Kronus Market Development Associates, Inc. | NST |
| May 22, 2008 | K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT Kronus Market Development Associates, Inc. | JZO |
| Apr 10, 2008 | K073590 | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT Kronus Market Development Associates, Inc. | OIF |
| Nov 7, 2007 | K072135 | KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT Kronus Market Development Associates, Inc. | NWG |
| Jul 13, 2007 | K070183 | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT Kronus Market Development Associates, Inc. | OCN |
| Nov 4, 2005 | K051061 | KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT Kronus Market Development Associates, Inc. | NWG |
| Dec 17, 2004 | K042248 | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT Kronus Market Development Associates, Inc. | NST |
| Sep 10, 2003 | K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT Kronus Market Development Associates, Inc. | JZO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||