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 a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2017-10-19 under approval 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. It is manufactured by Abbott Laboratories. The 510(k) number is K170316.
When was ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM approved by the FDA?
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM received FDA 510(k) clearance on 2017-10-19, under approval number K170316.
What company makes ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM?
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM is manufactured by Abbott Laboratories.
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
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