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FDA 510(k)

DIATRON BLOOD GLUCOSE METER

K-Number: K855178 · 1986-08-04

ApplicantDextron, Inc.
Decision Date1986-08-04
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIATRON BLOOD GLUCOSE METER is the device name listed in this FDA 510(k) record. The listed applicant is Dextron, Inc.. It received FDA 510(k) clearance on 1986-08-04 under 510(k) number K855178. 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 BLOOD GLUCOSE METER?

DIATRON BLOOD GLUCOSE METER is a medical device that received FDA 510(k) clearance on 1986-08-04. The listed applicant is Dextron, Inc.. The 510(k) number is K855178.

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

DIATRON BLOOD GLUCOSE METER received FDA 510(k) clearance on 1986-08-04, under 510(k) number K855178.

Who is the listed applicant for DIATRON BLOOD GLUCOSE METER?

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

What is the FDA product code for DIATRON BLOOD GLUCOSE METER?

The FDA product code for DIATRON BLOOD GLUCOSE METER 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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