510(k) K953084 ยท CFP Radioimmunoassay, Immunoreactive Insulin
ACCESS ULTRASENSITIVE INSULIN ASSAY
| Applicant | Bio-Rad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 25, 1995 |
| Received | Jul 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953084
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2024 | Beckman Coulter, Inc. Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410 Open, Classified |
CFP | None listed |
| Jun 25, 2008 | Beckman Coulter Inc Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of insulin levels in human serum an Terminated |
CFP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.