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FDA 510(k)

ABT GLUCOSE CONTROL SOLUTION

K-Number: K083549 · 2008-12-22

ApplicantAmerican Biological Technologies, Inc.
Decision Date2008-12-22
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABT GLUCOSE CONTROL SOLUTION 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 2008-12-22 under 510(k) number K083549. 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?

ABT GLUCOSE CONTROL SOLUTION is a medical device that received FDA 510(k) clearance on 2008-12-22. The listed applicant is American Biological Technologies, Inc.. The 510(k) number is K083549.

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

ABT GLUCOSE CONTROL SOLUTION received FDA 510(k) clearance on 2008-12-22, under 510(k) number K083549.

Who is the listed applicant for ABT GLUCOSE CONTROL SOLUTION?

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?

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

Related Clinical Trials

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.

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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: 2120089K090854ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090

Related Devices (Code: JJX)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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