Gradiplasma la High, Gradiplasma la Low Models LAHP-1, LAHP-05, LALP-1, LALP-05

Q: What is the product code of K993332?

The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.

FDA 510(k) K993332 · Gradipore , Ltd.

Substantially Equivalent

510(k) numberK993332

Submission

Device name: Gradiplasma la High, Gradiplasma la Low Models LAHP-1, LAHP-05, LALP-1, LALP-05
Applicant: Gradipore , Ltd.
North Ryde, AU
Received: October 4, 1999
Decision date: February 16, 2000
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GGC – Control, Plasma, Abnormal
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.5425
Specialty: Hematology

Other 510(k)s with product code GGC

510(k)	Device	Applicant	Decision
K102552	Hemosil la Positive ControlGGC · Traditional	Instrumentation Laboratory CO	04/05/2011SE
K100103	Specialty Assayed CONTROL-2GGC · Traditional	Helena Laboratories	12/15/2010SE
K062306	Plasmacon N, Plasmacon L-1, Plasmacon L-2GGC · Traditional	R2 Diagnostics, Inc.	03/16/2007SE
K061803	Sta - Control la 1+2GGC · Traditional	Diagnostica Stago, Inc.	07/28/2006SE
K032804	Cryocheck Weak Lupus Positive ControlGGC · Traditional	Precision Biologic	11/03/2003SE
K023312	Control Plasma PGGC · Traditional	Dade Behring, Inc.	11/01/2002SE
K020878	Lyphochek Hemostasis, Models 798, 799GGC · Traditional	Bio-Rad	04/15/2002SE
K020109	Sigma Diagnostics Accuclot la ControlGGC · Traditional	Sigma Diagnostics, Inc.	02/06/2002SE
K012422	K-Assay D-Dimer ControlsGGC · Traditional	Kamiya Biomedical Co.	08/21/2001SE
K003329	Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional	Sigma Diagnostics, Inc.	03/01/2001SE

More from Sigma Diagnostics, Inc.

510(k)	Device	Decision
K992456	Gradileiden V TestGGW · Traditional	12/21/1999SE
K922156	Lucor Confirmatory ReagentGIR · Traditional	04/06/1993SE
K903037	Lupo-Test ReagentGIR · Traditional	12/17/1990SE

Questions and answers

When was Gradiplasma la High, Gradiplasma la Low Models LAHP-1, LAHP-05, LALP-1, LALP-05 cleared by the FDA?

Gradiplasma la High, Gradiplasma la Low Models LAHP-1, LAHP-05, LALP-1, LALP-05 (K993332) received a 510(k) decision of Substantially Equivalent on February 16, 2000, 135 days after the submission was received.

What is the product code of K993332?

The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.