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FDA 510(k)

GLUCOSE (HEXOKINASE) DELTA TEST ASSAY

K-Number: K770262 · 1977-02-23

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1977-02-23
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE (HEXOKINASE) DELTA TEST ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1977-02-23 under 510(k) number K770262. 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) DELTA TEST ASSAY?

GLUCOSE (HEXOKINASE) DELTA TEST ASSAY is a medical device that received FDA 510(k) clearance on 1977-02-23. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K770262.

When did GLUCOSE (HEXOKINASE) DELTA TEST ASSAY receive FDA 510(k) clearance?

GLUCOSE (HEXOKINASE) DELTA TEST ASSAY received FDA 510(k) clearance on 1977-02-23, under 510(k) number K770262.

Who is the listed applicant for GLUCOSE (HEXOKINASE) DELTA TEST ASSAY?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOSE (HEXOKINASE) DELTA TEST ASSAY?

The FDA product code for GLUCOSE (HEXOKINASE) DELTA TEST ASSAY is CFR.

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Related Devices (Code: CFR)

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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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