K130020 is an FDA 510(k) clearance for the ACCESS TOTAL BHCG (5TH IS). This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II - Special Controls, product code DHA).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on October 1, 2013, 271 days after receiving the submission on January 3, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K130020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2013 |
| Decision Date | October 01, 2013 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DHA — System, Test, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |