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FDA 510(k)

DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI

K-Number: K801051 · 1980-05-23

ApplicantData Medical Associates, Inc.
Decision Date1980-05-23
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1980-05-23 under 510(k) number K801051. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI?

DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI is a medical device that received FDA 510(k) clearance on 1980-05-23. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K801051.

When did DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI receive FDA 510(k) clearance?

DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI received FDA 510(k) clearance on 1980-05-23, under 510(k) number K801051.

Who is the listed applicant for DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI?

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

What is the FDA product code for DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI?

The FDA product code for DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI is CFR.

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Related Devices (Code: CFR)

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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