K052082 is an FDA 510(k) clearance for the FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020. This device is classified as a Radioimmunoassay (two-site Solid Phase), Ferritin (Class II - Special Controls, product code JMG).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on August 19, 2005, 17 days after receiving the submission on August 2, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K052082 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2005 |
| Decision Date | August 19, 2005 |
| Days to Decision | 17 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JMG — Radioimmunoassay (two-site Solid Phase), Ferritin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |