The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Free T3 Calibrators On The Access Immunoassay Systems.
| Device ID | K042651 |
| 510k Number | K042651 |
| Device Name: | FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS |
| Classification | Calibrator, Secondary |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Valynda Machen |
| Correspondent | Valynda Machen BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-28 |
| Decision Date | 2004-10-05 |
| Summary: | summary |