Cleared Traditional

AggreGuide A-100 ADP

K181777 · Aggredyne, Inc. · Hematology
Mar 2019
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K181777 is an FDA 510(k) clearance for the AggreGuide A-100 ADP, 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 March 29, 2019, 269 days after receiving the submission on July 3, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K181777 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2018
Decision Date March 29, 2019
Days to Decision 269 days
Submission Type Traditional
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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