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FDA 510(k)

ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT

K-Number: K894394 · 1989-10-03

ApplicantAbbott Laboratories
Decision Date1989-10-03
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1989-10-03 under 510(k) number K894394. 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 ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT?

ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT is a medical device that received FDA 510(k) clearance on 1989-10-03. The listed applicant is Abbott Laboratories. The 510(k) number is K894394.

When did ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT receive FDA 510(k) clearance?

ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT received FDA 510(k) clearance on 1989-10-03, under 510(k) number K894394.

Who is the listed applicant for ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT?

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

What is the FDA product code for ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT?

The FDA product code for ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT 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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