K983340 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR. This device is classified as a Ferritin, Antigen, Antiserum, Control (Class II - Special Controls, product code DBF).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on December 14, 1998, 82 days after receiving the submission on September 23, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K983340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1998 |
| Decision Date | December 14, 1998 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DBF — Ferritin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |