K063232 is an FDA 510(k) clearance for the ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01. This device is classified as a Radioimmunoassay, Parathyroid Hormone (Class II - Special Controls, product code CEW).
Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on June 19, 2007, 237 days after receiving the submission on October 25, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1545.
| 510(k) Number | K063232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 2006 |
| Decision Date | June 19, 2007 |
| Days to Decision | 237 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 |