K170524 is an FDA 510(k) clearance for the Access AMH. This device is classified as a Anti-m�llerian Hormone Test System (Class II - Special Controls, product code PQO).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on November 13, 2017, 264 days after receiving the submission on February 22, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1092. An Anti-m�llerian Hormone Test System Is An In Vitro Diagnostic Device Intended To Measure Anti-m�llerian Hormone In Human Serum And Plasma. The Test Is Intended To Be Used As An Aid For Assessing Ovarian Reserve In Women..
| 510(k) Number | K170524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2017 |
| Decision Date | November 13, 2017 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PQO — Anti-müllerian Hormone Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1092 |
| Definition | An Anti-müllerian Hormone Test System Is An In Vitro Diagnostic Device Intended To Measure Anti-müllerian Hormone In Human Serum And Plasma. The Test Is Intended To Be Used As An Aid For Assessing Ovarian Reserve In Women. |