K223679 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 February 3, 2023, 57 days after receiving the submission on December 8, 2022.
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 | K223679 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2022 |
| Decision Date | February 03, 2023 |
| Days to Decision | 57 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. |