K071913 is an FDA 510(k) clearance for the IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01. This device is classified as a System, Test, Radioallergosorbent (rast) Immunological (Class II - Special Controls, product code DHB).
Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on August 24, 2007, 44 days after receiving the submission on July 11, 2007.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K071913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2007 |
| Decision Date | August 24, 2007 |
| Days to Decision | 44 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 |