510(k) K862359 ยท CIG Diazo Colorimetry, Bilirubin
METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
| Applicant | E.I. Dupont DE Nemours & Co., Inc., Wilmington DE, US |
| Decision | Substantially Equivalent, Aug 19, 1986 |
| Received | Jun 23, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
CIG | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Assays: Uric Acid (URCA) Terminated |
KNK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.