K882622 is an FDA 510(k) clearance for the CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM. This device is classified as a Indirect Copper Assay, Ceruloplasmin (Class II - Special Controls, product code JFR).
Submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on July 8, 1988, 14 days after receiving the submission on June 24, 1988.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5210.
| 510(k) Number | K882622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1988 |
| Decision Date | July 08, 1988 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JFR — Indirect Copper Assay, Ceruloplasmin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5210 |