Abt Glucose Control Solution, Model 2120090

FDA 510(k) K090854 · American Biological Technologies, Inc.

Substantially Equivalent

510(k) numberK090854

Submission

Device name
Abt Glucose Control Solution, Model 2120090
Applicant
American Biological Technologies, Inc.
Seguin, TX, US
Received
March 30, 2009
Decision date
April 16, 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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Questions and answers

When was Abt Glucose Control Solution, Model 2120090 cleared by the FDA?

Abt Glucose Control Solution, Model 2120090 (K090854) received a 510(k) decision of Substantially Equivalent on April 16, 2009, 17 days after the submission was received.

What is the product code of K090854?

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.