Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Aggredyne, Inc.. It received FDA 510(k) clearance on 2017-04-05 under 510(k) 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. The listed applicant is Aggredyne, Inc.. The 510(k) number is K163274.

When did AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument receive FDA 510(k) clearance?

AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument received FDA 510(k) clearance on 2017-04-05, under 510(k) number K163274.

Who is the listed applicant for AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument?

The FDA 510(k) record lists Aggredyne, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Aggredyne, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181777AggreGuide A-100 ADP

Related Devices (Code: JOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01Fujimori Kogyo, Co., Ltd.K181777AggreGuide A-100 ADPAggredyne, Inc.K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp.

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.

↑