Gradileiden V Test

Q: When was Gradileiden V Test cleared by the FDA?

Gradileiden V Test (K992456) received a 510(k) decision of Substantially Equivalent on December 21, 1999, 151 days after the submission was received.

Q: What is the product code of K992456?

The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.

FDA 510(k) K992456 · Gradipore , Ltd.

Substantially Equivalent

510(k) numberK992456

Submission

Device name: Gradileiden V Test
Applicant: Gradipore , Ltd.
North Ryde, AU
Received: July 23, 1999
Decision date: December 21, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GGW – Test, Time, Partial Thromboplastin
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.7925
Specialty: Hematology

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K982062	Cryo-Check PNP Platelet Lysate, Model PNP-10GGW · Traditional	Precision Biologicals, Inc.	01/13/1999SE
K963111	Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SGGW · Traditional	Chromogenix AB	12/23/1996SE
K945940	Coatest(R) Apc(Tm) ResistanceGGW · Traditional	Axis-Shield Doc AS	08/07/1995SE
K941210	Ptt-Lt Test KitGGW · Traditional	American Bioproducts Co.	03/21/1995SESK

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K922156	Lucor Confirmatory ReagentGIR · Traditional	04/06/1993SE
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Questions and answers

When was Gradileiden V Test cleared by the FDA?

Gradileiden V Test (K992456) received a 510(k) decision of Substantially Equivalent on December 21, 1999, 151 days after the submission was received.

What is the product code of K992456?

The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.