510(k) K022519 ยท JHM Colorimetric Method, Lipoproteins
LDL CHOLESTEROL (AUTOMATED)
| Applicant | Jas Diagnostics, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Sep 30, 2002 |
| Received | Jul 30, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2013 | Mindray DS USA, Inc. d.b.a. Mindray North America BS-200 Chemistry Analyzer
Designed for clinical laboratory use. Terminated |
CFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.