K013992 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (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 Juan Capistrano, US). The FDA issued a Cleared decision on December 13, 2001, 9 days after receiving the submission on December 4, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1545.
| 510(k) Number | K013992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2001 |
| Decision Date | December 13, 2001 |
| Days to Decision | 9 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 |