K061190 is an FDA 510(k) clearance for the ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953. This device is classified as a Radioimmunoassay, Parathyroid Hormone (Class II - Special Controls, product code CEW).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 15, 2006, 140 days after receiving the submission on April 28, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1545.
| 510(k) Number | K061190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2006 |
| Decision Date | September 15, 2006 |
| Days to Decision | 140 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 |