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FDA 510(k)

DIABETES ASSISTANT SOFTWARE

K-Number: K014139 · 2002-03-21

ApplicantRoche Diagnostics Corp.
Decision Date2002-03-21
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIABETES ASSISTANT SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2002-03-21 under 510(k) number K014139. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIABETES ASSISTANT SOFTWARE?

DIABETES ASSISTANT SOFTWARE is a medical device that received FDA 510(k) clearance on 2002-03-21. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K014139.

When did DIABETES ASSISTANT SOFTWARE receive FDA 510(k) clearance?

DIABETES ASSISTANT SOFTWARE received FDA 510(k) clearance on 2002-03-21, under 510(k) number K014139.

Who is the listed applicant for DIABETES ASSISTANT SOFTWARE?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIABETES ASSISTANT SOFTWARE?

The FDA product code for DIABETES ASSISTANT SOFTWARE is CGA.

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Official Source

View on FDA Database →

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

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