Ebv-Vca Igg Elisa Test, Model EBG-100

Q: What is the product code of K020706?

The FDA product code is GNP – Antiserum, Cf, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.

FDA 510(k) K020706 · Pan Bio Pty. , Ltd.

Substantially Equivalent

510(k) numberK020706

Submission

Device name: Ebv-Vca Igg Elisa Test, Model EBG-100
Applicant: Pan Bio Pty. , Ltd.
Windsor, AU
Received: March 4, 2002
Decision date: June 13, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GNP – Antiserum, Cf, Epstein-Barr Virus
Device class: Class I (low risk)
Regulation: 21 CFR 866.3235
Specialty: Microbiology

Other 510(k)s with product code GNP

510(k)	Device	Applicant	Decision
K020717	Ebv V Vca Igm Elisa Kit Model# EBM-200GNP · Traditional	Pan Bio Pty. , Ltd.	06/13/2002SE
K020707	Ebv-Ebna Igg Elisa Kit, Model EBG-100GNP · Traditional	Pan Bio Pty. , Ltd.	06/13/2002SE
K981831	Is Ebv-Ea-D Igg Elisa Test SystemGNP · Traditional	Diamedix Corp.	02/16/1999SE
K981829	Is EBV-EBNA-1 Igg Elisa Test SystemGNP · Traditional	Diamedix Corp.	02/16/1999SE
K901156	Eia for Igg Antibody to Ebv Vca in Human SerumGNP · Traditional	Granbio, Inc.	09/12/1990SE
K883670	Serological Test Kit for Igg Anti. Epstein-Barr ViGNP · Traditional	Electro-Nucleonics, Inc.	04/28/1989SE
K884591	Ebv-Vca Antibody (Igg)GNP · Traditional	Hillcrest Biologicals	01/24/1989SE
K880885	Ebv-Vca Igg Antibody Test System (Enzyme)GNP · Traditional	Immuno Concepts, Inc.	08/30/1988SE
K880883	Ebv-Vca Igg Antibody Test System (Fluorescent)GNP · Traditional	Immuno Concepts, Inc.	08/30/1988SE
K871373	Ebv-Check(Tm) Test Kit (Igg)GNP · Traditional	Diagnostic Technology, Inc.	06/25/1987SE

More from Diagnostic Technology, Inc.

510(k)	Device	Decision
K021793	Ebv Ea-D Igg Elisa Kit, Model EBG-100LSE · Traditional	09/27/2002SE
K020717	Ebv V Vca Igm Elisa Kit Model# EBM-200GNP · Traditional	06/13/2002SE
K020707	Ebv-Ebna Igg Elisa Kit, Model EBG-100GNP · Traditional	06/13/2002SE

Questions and answers

When was Ebv-Vca Igg Elisa Test, Model EBG-100 cleared by the FDA?

Ebv-Vca Igg Elisa Test, Model EBG-100 (K020706) received a 510(k) decision of Substantially Equivalent on June 13, 2002, 101 days after the submission was received.

What is the product code of K020706?

The FDA product code is GNP – Antiserum, Cf, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.