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FDA 510(k)

CAMIT DIABETES MANAGEMENT SOFTWARE

K-Number: K001907 · 2000-09-05

ApplicantRoche Diagnostics Corp.
Decision Date2000-09-05
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CAMIT DIABETES MANAGEMENT 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 2000-09-05 under 510(k) number K001907. 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 CAMIT DIABETES MANAGEMENT SOFTWARE?

CAMIT DIABETES MANAGEMENT SOFTWARE is a medical device that received FDA 510(k) clearance on 2000-09-05. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K001907.

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

CAMIT DIABETES MANAGEMENT SOFTWARE received FDA 510(k) clearance on 2000-09-05, under 510(k) number K001907.

Who is the listed applicant for CAMIT DIABETES MANAGEMENT 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 CAMIT DIABETES MANAGEMENT SOFTWARE?

The FDA product code for CAMIT DIABETES MANAGEMENT SOFTWARE is CGA.

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: 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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