510(k) K923504 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
CHOLESTEROL ENZYMATIC ENDPOINT
| Applicant | Randox Laboratories, Ltd., Antrim, N. Ireland, IR |
| Decision | Substantially Equivalent, Jan 10, 1994 |
| Received | Jul 15, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923504
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2022 | Randox Laboratories Ltd. Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma.
Catalog Number: CH2O0 Terminated |
CHH | None listed |
| Nov 1, 2021 | Randox Laboratories Ltd. RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum
REF: CH200 Terminated |
CHH | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Advia Chemistry Assay: LDL Cholesterol, Direct Terminated |
MRR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.