Blood Platelet Assay Method & Apparatus

Q: What is the product code of K862302?

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

FDA 510(k) K862302 · Bellhouse Medical, Inc.

Substantially Equivalent

510(k) numberK862302

Submission

Device name: Blood Platelet Assay Method & Apparatus
Applicant: Bellhouse Medical, Inc.
Washington, DC, US
Received: June 17, 1986
Decision date: July 31, 1986
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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)	Device	Applicant	Decision
K191364	T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL…JOZ · Traditional	Fujimori Kogyo, Co., Ltd.	02/14/2020SE
K181777	AggreGuide A-100 ADPJOZ · Traditional	Aggredyne, Inc.	03/29/2019SE
K163274	AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentJOZ · Special	Aggredyne, Inc.	04/05/2017SE
K161329	Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelJOZ · Special	Chrono-Log Corp.	12/02/2016SE
K141427	Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestJOZ · Traditional	Accumetrics, Inc.	07/24/2015SE
K140893	Cora (Coagulation Resonance Analysis) System with Platelet Mapping AssayJOZ · Traditional	Coramed Technologies, LLC	01/03/2015SE
K122162	AggreguideJOZ · Traditional	Aggredyne, Inc.	12/20/2013SE
K103555	Multiplate 5.0 AggregometerJOZ · Traditional	Verum Diagnostica GmbH	07/27/2012SE
K060489	Dade PFA-100 Platelet Function Analyzer and ReagentsJOZ · Traditional	Dade Behring, Inc.	07/21/2006SE
K050265	Chrono-Log Whole Blood Lumi-Aggregometer, Model 700JOZ · Traditional	Chrono-Log Corp.	10/14/2005SE

More from Chrono-Log Corp.

510(k)	Device	Decision
K905022	Aqua-Gard Waterproof Wound PatchKGX · Traditional	02/11/1991SE
K901228	Multi-StripFKX · Traditional	05/07/1990SE

Questions and answers

When was Blood Platelet Assay Method & Apparatus cleared by the FDA?

Blood Platelet Assay Method & Apparatus (K862302) received a 510(k) decision of Substantially Equivalent on July 31, 1986, 44 days after the submission was received.

What is the product code of K862302?

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