D-10 HEMOGLOBIN A1C— 510(k) K031043
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K031043 for D-10 HEMOGLOBIN A1C, Substantially Equivalent on 2003-08-27. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hercules, CA, US
Recent devices under product code LCP
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view allRecalls naming K031043
K-number listed on FDA's recall record- Z-1299-2014 — D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis.
- Z-0965-2014 — D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031043.
Data sourced from openFDA. This site is unofficial and independent of the FDA.