The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Total Bhcg (5th Is).
| Device ID | K130020 |
| 510k Number | K130020 |
| Device Name: | ACCESS TOTAL BHCG (5TH IS) |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Geraldine L Baglien |
| Correspondent | Geraldine L Baglien BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-03 |
| Decision Date | 2013-10-01 |
| Summary: | summary |