Abt Glucose Control Solution, Model: 2120089

FDA 510(k) K090943 · American Biological Technologies, Inc.

Substantially Equivalent

510(k) numberK090943

Submission

Device name
Abt Glucose Control Solution, Model: 2120089
Applicant
American Biological Technologies, Inc.
Seguin, TX, US
Received
April 3, 2009
Decision date
May 27, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

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More from Siemens Healthcare Diagnostics, Inc.

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K091460Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087JJX · Traditional 08/06/2009SE
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Questions and answers

When was Abt Glucose Control Solution, Model: 2120089 cleared by the FDA?

Abt Glucose Control Solution, Model: 2120089 (K090943) received a 510(k) decision of Substantially Equivalent on May 27, 2009, 54 days after the submission was received.

What is the product code of K090943?

The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.