Product Code: JBX FDA class 2 21 CFR 864.6675

Aggregrometer, Platelet

Hematology

A platelet aggregometer is a laboratory instrument used to assess platelet function by measuring the degree of aggregation that occurs when platelets in a patient's plasma are stimulated with various agonists, supporting the diagnosis of platelet disorders and monitoring of antiplatelet therapy. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JBX, regulated under 21 CFR 864.6675, within the Hematology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: JBX
Device Class: FDA class 2
Regulation Number: 864.6675
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 12 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K932566	AGGRO/LINK CONTROL SOFTWARE	Nov 02, 1993	Substantially Equivalent	Chrono-Log Corp.
K912774	ARACHIDONIC ACID	Aug 22, 1991	Substantially Equivalent	Helena Laboratories
K881829	PAT PLATELET AGGREGATION TEST	Jul 01, 1988	Substantially Equivalent	Streck Laboratories, Inc.
K862775	ASSERACHROM B-TG KIT	Oct 22, 1986	Substantially Equivalent	American Bioproducts Co.
K851025	AGGRO/LINK COMPUTER INTERFACE	Jun 12, 1985	Substantially Equivalent	Chrono-Log Corp.
K850592	PLATELET AGGREGATION REAGENT	May 13, 1985	Substantially Equivalent	Chrono-Log Corp.
K832929	RISTOCETIN PLATELET AGGREGA-REAGENT TEST	Sep 29, 1983	Substantially Equivalent	Sigma Chemical Co.
K830749	PLATELET AGGREGOMETER	May 16, 1983	Substantially Equivalent	Chrono-Log Corp.
K821005	PLATELET AGGREGATION PROFILER #PAP-4	Jun 01, 1982	Substantially Equivalent	Bio/Data Corp.
K811290	ARACHIDONIC ACID	Jul 27, 1981	Substantially Equivalent	Bio/Data Corp.
K781710	BUFFER, COLLAGEN REAGENT AND DILUENT	Oct 24, 1978	Substantially Equivalent	Diagnostica, Inc.
K760159	AGGREGOMETER, DUAL CHANNEL PLATELET	Jul 20, 1976	Substantially Equivalent	Chrono-Log Corp.