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Medical Devices / Submissions and Approvals

Hitachi Chemical Receives 510(k) Clearance for Multiplex Allergy Tester

March 22, 2019
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The FDA has given the go-ahead for Hitachi Chemical Diagnostics’ OPTIGEN AP 3600, a high capacity allergy testing device.

The device performs panel allergy diagnoses and is able to process up to 100 panels—or 3,600 individual allergen results—in a day.

The system is fully automated and includes internal barcode scanners to identify samples and results. It also comes with a controller that automatically checks device performance before each analysis.

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