Cleared Special

AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument

K163274 · Aggredyne, Inc. · Hematology
Apr 2017
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K163274 is an FDA 510(k) clearance for the AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument, a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Aggredyne, Inc. (Houston, US). The FDA issued a Cleared decision on April 5, 2017, 135 days after receiving the submission on November 21, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K163274 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2016
Decision Date April 05, 2017
Days to Decision 135 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOZ — System, Automated Platelet Aggregation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700

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