D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM— 510(k) K060001

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

2006-01-03

Decision date

2006-01-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Hercules, CA, US

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• Z-0695-2016 — D-10 Rack Loader; Model Number 220-0600; Hematology: 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.Class II·Terminated·Bio-Rad Laboratories, Inc.·20151215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060001.