Thrombo-Cetin (Ristocetin)

FDA 510(k) K770395 · Bay Area Hema. Onco. Clinic. & Res. L

Substantially Equivalent

510(k) numberK770395

Submission

Device name
Thrombo-Cetin (Ristocetin)
Applicant
Bay Area Hema. Onco. Clinic. & Res. L
Mchenry, IL, US
Received
February 28, 1977
Decision date
March 21, 1977
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

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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
K181777AggreGuide A-100 ADPJOZ · Traditional Aggredyne, Inc.03/29/2019SE
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

More from Chrono-Log Corp.

510(k)DeviceDecision
K771678Thrombo-Screen Platelet AdhesionJBZ · Traditional 11/22/1977SE
K770722Thrombo Screen Quantitative Heparin AssaJBR · Traditional 07/11/1977SE
K770394Thrombo-Screen AT-111 KitJBQ · Traditional 03/30/1977SE

Questions and answers

When was Thrombo-Cetin (Ristocetin) cleared by the FDA?

Thrombo-Cetin (Ristocetin) (K770395) received a 510(k) decision of Substantially Equivalent on March 21, 1977, 21 days after the submission was received.

What is the product code of K770395?

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