K983617 is an FDA 510(k) clearance for the 25-HYDROXYVITAMIN D 125I RIA KIT. This device is classified as a Automated Radioimmunoassay Systems, For Clinical Use (Class I - General Controls, product code LCI).
Submitted by DiaSorin, Inc. (Columbia, US). The FDA issued a Cleared decision on November 16, 1998, 32 days after receiving the submission on October 15, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K983617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1998 |
| Decision Date | November 16, 1998 |
| Days to Decision | 32 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCI — Automated Radioimmunoassay Systems, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2050 |