ARCHITECT BNP ASSAY, MODEL 8K28— 510(k) K060964
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K060964 for ARCHITECT BNP ASSAY, MODEL 8K28, Substantially Equivalent on 2006-05-25. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code NBC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code NBC
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view allRecalls naming K060964
K-number listed on FDA's recall record- Z-2078-2019 — ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.
- Z-2079-2019 — ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060964.
Data sourced from openFDA. This site is unofficial and independent of the FDA.