Glucoscot II Blood Glucose Test System

FDA 510(k) K870708 · Kyoto Daiichi Kagaku Co., Ltd.

Substantially Equivalent

510(k) numberK870708

Submission

Device name
Glucoscot II Blood Glucose Test System
Applicant
Kyoto Daiichi Kagaku Co., Ltd.
Kyoto, 601, JP
Received
February 20, 1987
Decision date
February 2, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LFR – Glucose Dehydrogenase, Glucose
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

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Questions and answers

When was Glucoscot II Blood Glucose Test System cleared by the FDA?

Glucoscot II Blood Glucose Test System (K870708) received a 510(k) decision of Substantially Equivalent on February 2, 1988, 347 days after the submission was received.

What is the product code of K870708?

The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.