The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Amh.
| Device ID | K170524 |
| 510k Number | K170524 |
| Device Name: | Access AMH |
| Classification | Anti-müllerian Hormone Test System |
| Applicant | Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 -1084 |
| Contact | Debbie Kidder |
| Correspondent | Debbie Kidder Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 -1084 |
| Product Code | PQO |
| CFR Regulation Number | 862.1092 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-22 |
| Decision Date | 2017-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590669263 | K170524 | 000 |