DeviceClearance

AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument— 510(k) K163274

Substantially Equivalent

Aggredyne, Inc.

FDA 510(k) clearance K163274 for AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument, Substantially Equivalent on 2017-04-05. Applicant: Aggredyne, Inc..

Clearance details

Applicant
Aggredyne, Inc.
Product code
Code JOZ
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Houston, TX, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.