DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT— 510(k) K043378

Name: FDA 510(k) clearance K043378
Creator: U.S. Food and Drug Administration
Published: 2004-12-29

Substantially Equivalent

Drew Scientific , Ltd.

FDA 510(k) clearance K043378 for DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT, Substantially Equivalent on 2004-12-29. Applicant: Drew Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Drew Scientific , Ltd.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2004-12-08
Decision date: 2004-12-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Barrow In Furness Cumbria, GB

Download summary PDF View on FDA.gov ↗

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