AggreGuide A-100 ADP

FDA 510(k) K181777 · Aggredyne, Inc.

Substantially Equivalent

510(k) numberK181777

Submission

Device name
AggreGuide A-100 ADP
Applicant
Aggredyne, Inc.
Houston, TX, US
Received
July 3, 2018
Decision date
March 29, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOZ – System, Automated Platelet Aggregation
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5700
Specialty
Hematology

Other 510(k)s with product code JOZ

510(k)DeviceApplicantDecision
K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL…JOZ · Traditional Fujimori Kogyo, Co., Ltd.02/14/2020SE
K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentJOZ · Special Aggredyne, Inc.04/05/2017SE
K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelJOZ · Special Chrono-Log Corp.12/02/2016SE
K141427Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestJOZ · Traditional Accumetrics, Inc.07/24/2015SE
K140893Cora (Coagulation Resonance Analysis) System with Platelet Mapping AssayJOZ · Traditional Coramed Technologies, LLC01/03/2015SE
K122162AggreguideJOZ · Traditional Aggredyne, Inc.12/20/2013SE
K103555Multiplate 5.0 AggregometerJOZ · Traditional Verum Diagnostica GmbH07/27/2012SE
K060489Dade PFA-100 Platelet Function Analyzer and ReagentsJOZ · Traditional Dade Behring, Inc.07/21/2006SE
K050265Chrono-Log Whole Blood Lumi-Aggregometer, Model 700JOZ · Traditional Chrono-Log Corp.10/14/2005SE
K051231VERIFYNOW-P2Y12 AssayJOZ · Traditional Accumetrics, Inc.08/05/2005SE

More from Accumetrics, Inc.

510(k)DeviceDecision
K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentJOZ · Special 04/05/2017SE
K122162AggreguideJOZ · Traditional 12/20/2013SE

Questions and answers

When was AggreGuide A-100 ADP cleared by the FDA?

AggreGuide A-100 ADP (K181777) received a 510(k) decision of Substantially Equivalent on March 29, 2019, 269 days after the submission was received.

What is the product code of K181777?

The FDA product code is JOZ – System, Automated Platelet Aggregation, a Class II (moderate risk) device regulated under 21 CFR 864.5700.