Ristocetin

FDA 510(k) K900792 · Medical Diagnostic Technologies, Inc.

Substantially Equivalent

510(k) numberK900792

Submission

Device name
Ristocetin
Applicant
Medical Diagnostic Technologies, Inc.
Ventura, CA, US
Received
February 20, 1990
Decision date
March 27, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

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K922800Platelet Aggregation ReagentsGHR · Traditional Chrono-Log Corp.08/26/1992SE
K910800Adp ReagentGHR · Traditional Helena Laboratories05/20/1991SE
K910706Collagen Reagent Cat. No. 5368GHR · Traditional Helena Laboratories05/20/1991SE
K910680Epinephrine Reagent, Cat. No. 5367GHR · Traditional Helena Laboratories05/20/1991SE
K910286Platelet Aggregation ReagentsGHR · Traditional Medical Diagnostic Technologies, Inc.03/19/1991SE
K832428Platelet Aggregation Reagent SetGHR · Traditional Helena Laboratories10/20/1983SE
K820422Platelet AggregometersGHR · Traditional Chrono-Log Corp.03/16/1982SE
K760198Kit, Platelet Aggregation Reagent (#390)GHR · Traditional Chrono-Log Corp.07/19/1976SE

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K962489Chromolize Tpa Assay KitGGP · Traditional 07/31/1996SE
K960438Tintelize PAI-1 KitGGP · Traditional 06/05/1996SE
K961724U-Doa ControlsDIF · Traditional 06/03/1996SE
K961370La Positive Control PlasmaGGC · Traditional 05/24/1996SE
K955115Venom Tiem ReagentJCO · Traditional 04/03/1996SE
K955738Bioclot Protein SGGP · Traditional 02/29/1996SE

Questions and answers

When was Ristocetin cleared by the FDA?

Ristocetin (K900792) received a 510(k) decision of Substantially Equivalent on March 27, 1990, 35 days after the submission was received.

What is the product code of K900792?

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