Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087

FDA 510(k) K091460 · American Biological Technologies, Inc.

Substantially Equivalent

510(k) numberK091460

Submission

Device name
Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087
Applicant
American Biological Technologies, Inc.
Seguin, TX, US
Received
May 18, 2009
Decision date
August 6, 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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Questions and answers

When was Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087 cleared by the FDA?

Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087 (K091460) received a 510(k) decision of Substantially Equivalent on August 6, 2009, 80 days after the submission was received.

What is the product code of K091460?

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.