K092050 is an FDA 510(k) clearance for the IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01. This device is classified as a System, Test, Radioallergosorbent (rast) Immunological (Class II - Special Controls, product code DHB).
Submitted by Phadia AB (Portage, US). The FDA issued a Cleared decision on November 20, 2009, 136 days after receiving the submission on July 7, 2009.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K092050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2009 |
| Decision Date | November 20, 2009 |
| Days to Decision | 136 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 |