K915838 is an FDA 510(k) clearance for the OPUS FERRITIN TEST SYSTEM. This device is classified as a Igd, Rhodamine, Antigen, Antiserum, Control (Class II — Special Controls, product code DGE).
Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on March 18, 1992, 85 days after receiving the submission on December 24, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K915838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1991 |
| Decision Date | March 18, 1992 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DGE — Igd, Rhodamine, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5510 |