The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Tpo Antibody, And Access Tpo Antibody Calibrators, Models A12985 And A18227.
| Device ID | K061382 |
| 510k Number | K061382 |
| Device Name: | ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Valynda L Machen |
| Correspondent | Valynda L Machen BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-18 |
| Decision Date | 2006-07-06 |
| Summary: | summary |