Chlamydia Tissue Culture Confirmation Test (Eia)

Q: What is the product code of K862948?

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) K862948 · Intercare Diagnostics, Inc.

Substantially Equivalent

510(k) numberK862948

Submission

Device name: Chlamydia Tissue Culture Confirmation Test (Eia)
Applicant: Intercare Diagnostics, Inc.
Berkeley, CA, US
Received: August 5, 1986
Decision date: October 17, 1986
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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
K941938	The Mirage System Biofeedback InterfaceHCC · Traditional	08/05/1994SE
K920569	Indxtm Dip-S-TickstmLSQ · Traditional	02/09/1993SE
K901597	Indx Dip S TicksLSQ · Traditional	12/21/1990SE
K893895	Hematology Control Mixtures for Quality ControlJPK · Traditional	07/25/1989SE

Questions and answers

When was Chlamydia Tissue Culture Confirmation Test (Eia) cleared by the FDA?

Chlamydia Tissue Culture Confirmation Test (Eia) (K862948) received a 510(k) decision of Substantially Equivalent on October 17, 1986, 73 days after the submission was received.

What is the product code of K862948?

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