GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM— 510(k) K870708

Substantially Equivalent

Kyoto Daiichi Kagaku Co., Ltd.

FDA 510(k) clearance K870708 for GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM, Substantially Equivalent on 1988-02-02. Applicant: Kyoto Daiichi Kagaku Co., Ltd..

Clearance details

Applicant: Kyoto Daiichi Kagaku Co., Ltd.
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 1987-02-20
Decision date: 1988-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kyoto, 601, JP

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Adverse events under product code LFR

product code LFR

Death: 3
Malfunction: 1,634
Total: 1,637

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.