AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
K-Number: K163274 · 2017-04-05
ApplicantAggredyne, Inc.
Decision Date2017-04-05
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument is a medical device manufactured by Aggredyne, Inc.. It received FDA 510(k) clearance on 2017-04-05 under approval number K163274. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument?
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument is a medical device that received FDA 510(k) clearance on 2017-04-05. It is manufactured by Aggredyne, Inc.. The 510(k) number is K163274.
When was AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument approved by the FDA?
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument received FDA 510(k) clearance on 2017-04-05, under approval number K163274.
What company makes AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument?
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument is manufactured by Aggredyne, Inc..
What is the FDA product code for AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument?
The FDA product code for AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument is JOZ.
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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.