The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Tsh (3rd Is) Assay And Access Tsh (3rd Is) Calibrators On The Access Immunoassay Systems.
| Device ID | K153651 |
| 510k Number | K153651 |
| Device Name: | Access TSH (3RD IS) Assay And Access TSH (3RD IS) Calibrators On The Access Immunoassay Systems |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BECKMAN COULTER, INC. Immunodiagnostic Development Center 1000 LAKE HAZELTINE DRIVE Chaska, MN 55318 -1361 |
| Contact | Michael Robert Lorenz |
| Correspondent | Michael Robert Lorenz BECKMAN COULTER, INC. Immunodiagnostic Development Center 1000 LAKE HAZELTINE DRIVE Chaska, MN 55318 -1361 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590671501 | K153651 | 000 |
| 15099590671495 | K153651 | 000 |