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FDA 510(k)

LINEAR ENZYMATIC GLUCOSE SYSTEM

K-Number: K800200 · 1980-02-21

ApplicantSimmler, Inc.
Decision Date1980-02-21
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LINEAR ENZYMATIC GLUCOSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1980-02-21 under 510(k) number K800200. 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 LINEAR ENZYMATIC GLUCOSE SYSTEM?

LINEAR ENZYMATIC GLUCOSE SYSTEM is a medical device that received FDA 510(k) clearance on 1980-02-21. The listed applicant is Simmler, Inc.. The 510(k) number is K800200.

When did LINEAR ENZYMATIC GLUCOSE SYSTEM receive FDA 510(k) clearance?

LINEAR ENZYMATIC GLUCOSE SYSTEM received FDA 510(k) clearance on 1980-02-21, under 510(k) number K800200.

Who is the listed applicant for LINEAR ENZYMATIC GLUCOSE SYSTEM?

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

What is the FDA product code for LINEAR ENZYMATIC GLUCOSE SYSTEM?

The FDA product code for LINEAR ENZYMATIC GLUCOSE SYSTEM is CGA.

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Other records listing Simmler, Inc. 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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