K060348 is an FDA 510(k) clearance for the MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT. This device is classified as a Radioimmunoassay, Parathyroid Hormone (Class II - Special Controls, product code CEW).
Submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on February 27, 2006, 17 days after receiving the submission on February 10, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1545.
| 510(k) Number | K060348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2006 |
| Decision Date | February 27, 2006 |
| Days to Decision | 17 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CEW — Radioimmunoassay, Parathyroid Hormone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1545 |