Quicktek Blood Glucose System, Quicktek Blood Glucose Meter, Quicktek Blood Glucose Strips, Quicktek Control Solution

FDA 510(k) K010039 · Chronimed, Inc.

Substantially Equivalent

510(k) numberK010039

Submission

Device name
Quicktek Blood Glucose System, Quicktek Blood Glucose Meter, Quicktek Blood Glucose Strips, Quicktek Control Solution
Applicant
Chronimed, Inc.
Eden Prairie, MN, US
Received
January 5, 2001
Decision date
August 10, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NBW – System, Test, Blood Glucose, Over The Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

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More from Ascensia Diabetes Care

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K983432Supreme II Control SolutionsJJX · Traditional 12/17/1998SE
K980573Sensorex Blood Glucose Monitoring SystemCGA · Traditional 07/30/1998SE
K981555Diascreen Reagent StripsLJX · Traditional 06/01/1998SE
K963544Supreme II MeterCGA · Traditional 02/20/1997SE

Questions and answers

When was Quicktek Blood Glucose System, Quicktek Blood Glucose Meter, Quicktek Blood Glucose Strips, Quicktek Control Solution cleared by the FDA?

Quicktek Blood Glucose System, Quicktek Blood Glucose Meter, Quicktek Blood Glucose Strips, Quicktek Control Solution (K010039) received a 510(k) decision of Substantially Equivalent on August 10, 2001, 217 days after the submission was received.

What is the product code of K010039?

The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.