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FDA 510(k)

ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090

K-Number: K090854 · 2009-04-16

ApplicantAmerican Biological Technologies, Inc.
Decision Date2009-04-16
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 is the device name listed in this FDA 510(k) record. The listed applicant is American Biological Technologies, Inc.. It received FDA 510(k) clearance on 2009-04-16 under 510(k) number K090854. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090?

ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 is a medical device that received FDA 510(k) clearance on 2009-04-16. The listed applicant is American Biological Technologies, Inc.. The 510(k) number is K090854.

When did ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 receive FDA 510(k) clearance?

ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 received FDA 510(k) clearance on 2009-04-16, under 510(k) number K090854.

Who is the listed applicant for ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090?

The FDA 510(k) record lists American Biological Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090?

The FDA product code for ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 is JJX.

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Other records listing American Biological Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091460ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087K090943ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089K083549ABT GLUCOSE CONTROL SOLUTION

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Official Source

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