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FDA 510(k)

DIATRON EASYTEST BLOOD GLUCOSE MONI

K-Number: K840484 · 1984-06-22

ApplicantMedivix, Inc.
Decision Date1984-06-22
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIATRON EASYTEST BLOOD GLUCOSE MONI is the device name listed in this FDA 510(k) record. The listed applicant is Medivix, Inc.. It received FDA 510(k) clearance on 1984-06-22 under 510(k) number K840484. 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 DIATRON EASYTEST BLOOD GLUCOSE MONI?

DIATRON EASYTEST BLOOD GLUCOSE MONI is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Medivix, Inc.. The 510(k) number is K840484.

When did DIATRON EASYTEST BLOOD GLUCOSE MONI receive FDA 510(k) clearance?

DIATRON EASYTEST BLOOD GLUCOSE MONI received FDA 510(k) clearance on 1984-06-22, under 510(k) number K840484.

Who is the listed applicant for DIATRON EASYTEST BLOOD GLUCOSE MONI?

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

What is the FDA product code for DIATRON EASYTEST BLOOD GLUCOSE MONI?

The FDA product code for DIATRON EASYTEST BLOOD GLUCOSE MONI is CGA.

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Related Devices (Code: CGA)

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

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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