K091289 is an FDA 510(k) clearance for the IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT. This device is classified as a System, Test, Radioallergosorbent (rast) Immunological (Class II - Special Controls, product code DHB).
Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on August 6, 2009, 97 days after receiving the submission on May 1, 2009.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K091289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2009 |
| Decision Date | August 06, 2009 |
| Days to Decision | 97 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 |