DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT— 510(k) K060510

Clearance details

Applicant

Drew Scientific , Ltd.

Product code

Code JJX

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

2006-02-27

Decision date

2006-06-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Barrow In Furness Cumbria, GB

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Other

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →