510(k) K053253 ยท KQO Automated Urinalysis System
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
| Applicant | Hemocue AB, Lake Forest CA, US |
| Decision | Substantially Equivalent, Feb 17, 2006 |
| Received | Nov 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053253
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2013 | HemoCue AB HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden
The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, th Terminated |
KQO | None listed |
| Dec 28, 2012 | HemoCue AB Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capi Terminated |
JIQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.