Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel | 84505 | Minaris Medical America, Inc. | DHB | 00813382010129 |
| CLA® Allergen-Specific IgE Assay - Eastern | 84502 | Minaris Medical America, Inc. | DHB | 00813382010105 |
| CLA® Allergen-Specific IgE Assay - Pediatric Comprehensive Panel | 84506 | Minaris Medical America, Inc. | DHB | 00813382010136 |
| CLA® Allergen-Specific IgE Assay - Eastern | 84508 | Minaris Medical America, Inc. | DHB | 00813382010334 |
| CLA® Allergen-Specific IgE Assay - Western Inhalant Panel | 84511 | Minaris Medical America, Inc. | DHB | 00813382010167 |
| CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel | 84507 | Minaris Medical America, Inc. | DHB | 00813382010143 |
| CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel | 84509 | Minaris Medical America, Inc. | DHB | 00813382010150 |
| CLA® Allergen-Specific IgE Assay - Moderate Food Panel | 84518 | Minaris Medical America, Inc. | DHB | 00813382010174 |