HEMOCUE ALBUMIN 201 ANALYZING SYSTEM— 510(k) K053253
Substantially EquivalentHemocue AB
FDA 510(k) clearance K053253 for HEMOCUE ALBUMIN 201 ANALYZING SYSTEM, Substantially Equivalent on 2006-02-17. Applicant: Hemocue AB. Device class: 1.
Clearance details
- Applicant
- Hemocue AB
- Product code
- Code KQO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2900
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, CA, US
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More clearances from Hemocue AB
view allRecalls naming K053253
K-number listed on FDA's recall record- Z-0086-2014 — 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, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes
- Z-0619-2013 — 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 capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053253.
Data sourced from openFDA. This site is unofficial and independent of the FDA.