K101251 is an FDA 510(k) clearance for the IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN. 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 May 27, 2011, 388 days after receiving the submission on May 4, 2010.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K101251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2010 |
| Decision Date | May 27, 2011 |
| Days to Decision | 388 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 |