K191510 is an FDA 510(k) clearance for the Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae. 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 July 31, 2019, 55 days after receiving the submission on June 6, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K191510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2019 |
| Decision Date | July 31, 2019 |
| Days to Decision | 55 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 |