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FDA 510(k)

AggreGuide A-100 ADP

K-Number: K181777 · 2019-03-29

ApplicantAggredyne, Inc.
Decision Date2019-03-29
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AggreGuide A-100 ADP is the device name listed in this FDA 510(k) record. The listed applicant is Aggredyne, Inc.. It received FDA 510(k) clearance on 2019-03-29 under 510(k) number K181777. 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 ADP?

AggreGuide A-100 ADP is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Aggredyne, Inc.. The 510(k) number is K181777.

When did AggreGuide A-100 ADP receive FDA 510(k) clearance?

AggreGuide A-100 ADP received FDA 510(k) clearance on 2019-03-29, under 510(k) number K181777.

Who is the listed applicant for AggreGuide A-100 ADP?

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 ADP?

The FDA product code for AggreGuide A-100 ADP 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.

K163274AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument

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.K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, 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.

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