K200825 is an FDA 510(k) clearance for the NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus. This device is classified as a System, Test, Radioallergosorbent (rast) Immunological (Class II - Special Controls, product code DHB).
Submitted by Hycor Biomedical (Garden Grove, US). The FDA issued a Cleared decision on June 26, 2020, 88 days after receiving the submission on March 30, 2020.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K200825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2020 |
| Decision Date | June 26, 2020 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DHB - System, Test, Radioallergosorbent (rast) Immunological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5750 |