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FDA 510(k)

GLUCOSE HEXOKINASE, AUTO K

K-Number: K781723 · 1978-11-03

ApplicantMedical Analysis Systems, Inc.
Decision Date1978-11-03
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE HEXOKINASE, AUTO K is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781723. 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 GLUCOSE HEXOKINASE, AUTO K?

GLUCOSE HEXOKINASE, AUTO K is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K781723.

When did GLUCOSE HEXOKINASE, AUTO K receive FDA 510(k) clearance?

GLUCOSE HEXOKINASE, AUTO K received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781723.

Who is the listed applicant for GLUCOSE HEXOKINASE, AUTO K?

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

What is the FDA product code for GLUCOSE HEXOKINASE, AUTO K?

The FDA product code for GLUCOSE HEXOKINASE, AUTO K 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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