Abt Glucose Control Solution

Q: What is the product code of K083549?

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.

FDA 510(k) K083549 · American Biological Technologies, Inc.

Substantially Equivalent

510(k) numberK083549

Submission

Device name: Abt Glucose Control Solution
Applicant: American Biological Technologies, Inc.
Seguin, TX, US
Received: December 1, 2008
Decision date: December 22, 2008
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.

510(k)	Device	Decision
K091460	Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087JJX · Traditional	08/06/2009SE
K090943	Abt Glucose Control Solution, Model: 2120089JJX · Traditional	05/27/2009SE
K090854	Abt Glucose Control Solution, Model 2120090JJX · Traditional	04/16/2009SE

Questions and answers

When was Abt Glucose Control Solution cleared by the FDA?

Abt Glucose Control Solution (K083549) received a 510(k) decision of Substantially Equivalent on December 22, 2008, 21 days after the submission was received.

What is the product code of K083549?

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.