K033727 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY. This device is classified as a Radioimmunoassay, Parathyroid Hormone (Class II - Special Controls, product code CEW).
Submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on April 22, 2004, 146 days after receiving the submission on November 28, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1545.
| 510(k) Number | K033727 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2003 |
| Decision Date | April 22, 2004 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| 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 |