510(k) K982250 ยท CEC Radioimmunoassay, Free Thyroxine
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
| Applicant | Beckman Instruments, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jul 14, 1998 |
| Received | Jun 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982250
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2020 | Beckman Coulter Inc. Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including:
Access 2, UniCel DxI 600, UniCel DxI 8 Terminated |
CEC | None listed |
| May 9, 2017 | Beckman Coulter Inc. Access System-Free T4 Assay, B01902E, Catalog No. 33880 Terminated |
CEC | None listed |
| Apr 11, 2011 | Beckman Coulter Inc. Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769
The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxi Terminated |
CEC | None listed |
| Oct 1, 2010 | Beckman Coulter Inc. Access Immunoassay Systems Free T4, Part Number: 33880 Terminated |
CEC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.