510(k) K072018 ยท CFR Hexokinase, Glucose
BS-200 CHEMISTRY ANALYZER, MODE BS-200
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, Feb 1, 2008 |
| Received | Jul 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072018
| 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.