Generic Blood Glucose Test Strip

FDA 510(k) K001092 · Inbios Intl., Inc.

Substantially Equivalent

510(k) numberK001092

Submission

Device name
Generic Blood Glucose Test Strip
Applicant
Inbios Intl., Inc.
Seattle, WA, US
Received
April 4, 2000
Decision date
July 26, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

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

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Questions and answers

When was Generic Blood Glucose Test Strip cleared by the FDA?

Generic Blood Glucose Test Strip (K001092) received a 510(k) decision of Substantially Equivalent on July 26, 2000, 113 days after the submission was received.

What is the product code of K001092?

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