K925848 is an FDA 510(k) clearance for the IMMULITE FERRITIN. This device is classified as a Radioimmunoassay (two-site Solid Phase), Ferritin (Class II - Special Controls, product code JMG).
Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on January 13, 1993, 56 days after receiving the submission on November 18, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K925848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1992 |
| Decision Date | January 13, 1993 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | JMG — Radioimmunoassay (two-site Solid Phase), Ferritin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |