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FDA 510(k)

ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM

K-Number: K170316 · 2017-10-19

ApplicantAbbott Laboratories
Decision Date2017-10-19
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2017-10-19 under 510(k) number K170316. 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 ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM?

ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Abbott Laboratories. The 510(k) number is K170316.

When did ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM receive FDA 510(k) clearance?

ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM received FDA 510(k) clearance on 2017-10-19, under 510(k) number K170316.

Who is the listed applicant for ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM?

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 ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM?

The FDA product code for ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM is 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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