The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Modification To Access Hypersensitive Htsh Assay.
| Device ID | K042281 |
| 510k Number | K042281 |
| Device Name: | MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Barbara Stegmeier |
| Correspondent | Barbara Stegmeier BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-24 |
| Decision Date | 2004-09-16 |
| Summary: | summary |