Seroelisa(Tm) Chlamydia Iga Test Kit

Q: What is the product code of K914327?

The FDA product code is LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), a Class I (low risk) device regulated under 21 CFR 866.3120.

FDA 510(k) K914327 · Savyon Diagnostics , Ltd.

Substantially Equivalent

510(k) numberK914327

Submission

Device name: Seroelisa(Tm) Chlamydia Iga Test Kit
Applicant: Savyon Diagnostics , Ltd.
Ashdod, IL
Received: September 27, 1991
Decision date: June 9, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Device class: Class I (low risk)
Regulation: 21 CFR 866.3120
Specialty: Microbiology

Other 510(k)s with product code LJC

510(k)	Device	Applicant	Decision
K032330	CT OiaLJC · Traditional	Thermo Biostar, Inc.	03/02/2004SE
K033865	Ideia Pce ChlamydiaLJC · Special	Dakocytomation, Ltd.	01/21/2004SE
K033079	Chlamydia Igg Elisa Test SystemLJC · Traditional	Trinity Biotech USA	11/26/2003SE
K982210	Modification of Syva Microtrak II Chlamydia EiaLJC · Special	Dade Behring, Inc.	07/09/1998SE
K962558	Chlamydia Igg Elisa Test SystemLJC · Traditional	Armkel, LLC	02/24/1997SE
K960850	Access Chlamydia AssayLJC · Traditional	Bio-Rad Laboratories, Inc.	02/04/1997SE
K955627	Vidas Chlamydia Blocking AssayLJC · Traditional	Biomerieux Vitek, Inc.	10/07/1996SE
K936054	Imx Select ChlamydiaLJC · Traditional	Abbott Laboratories	05/30/1996SE
K940564	Ideia(Tm) Chlamydia Blocking Reagents, ModificationLJC · Traditional	Dako Diagnostics , Ltd.	01/11/1996SE
K951010	Chlamydia OiaLJC · Traditional	Biostar, Inc.	10/07/1995SE

More from Biostar, Inc.

510(k)	Device	Decision
K921045	Diaslide Urine Culturing DeviceJXA · Traditional	09/28/1992SE
K915281	Serolisa Chlamydia Igg Test KitLJC · Traditional	03/23/1992SE
K910644	Ipazyme (TM) Chlamydia Igg-IgaLKH · Traditional	03/19/1991SE
K901975	Ipazyme(Tm) Chlamydia True Igm(Tm)LKH · Traditional	03/08/1991SE

Questions and answers

When was Seroelisa(Tm) Chlamydia Iga Test Kit cleared by the FDA?

Seroelisa(Tm) Chlamydia Iga Test Kit (K914327) received a 510(k) decision of Substantially Equivalent on June 9, 1992, 256 days after the submission was received.

What is the product code of K914327?

The FDA product code is LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), a Class I (low risk) device regulated under 21 CFR 866.3120.