Modified Chlamydia Direct Specimen Test Kit

Q: What is the product code of K871278?

The FDA product code is LJP – Antiserum, Fluorescent, Chlamydia Trachomatis, a Class I (low risk) device regulated under 21 CFR 866.3120.

FDA 510(k) K871278 · California Integrated Diagnostics, Inc.

Substantially Equivalent

510(k) numberK871278

Submission

Device name: Modified Chlamydia Direct Specimen Test Kit
Applicant: California Integrated Diagnostics, Inc.
Berkeley, CA, US
Received: March 31, 1987
Decision date: April 8, 1987
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: LJP – Antiserum, Fluorescent, Chlamydia Trachomatis
Device class: Class I (low risk)
Regulation: 21 CFR 866.3120
Specialty: Microbiology

Other 510(k)s with product code LJP

510(k)	Device	Applicant	Decision
K063675	Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation KitLJP · Traditional	Diagnostic Hybrids, Inc.	09/24/2007SE
K941714	Chlamydia Trachomatis Antigen TestLJP · Traditional	Neogenex	07/18/1994SE
K901243	Chlamydia-Cel Immunofluorenscence (If) TestLJP · Traditional	Cel Labs Pty, Ltd.	05/21/1990SE
K900870	Pathodx Chlamydia Trachomatis Direct Specimen TestLJP · Traditional	Diagnostic Products Corp.	04/16/1990SE
K895839	Pathodx Chlamydia Culture Confirmation PKCC1LJP · Traditional	Diagnostic Products Corp.	02/01/1990SE
K883352	Fluorescein Conjugated Anti-Chlamydia Mono AntiLJP · Traditional	Whittaker Bioproducts, Inc.	10/06/1988SE
K881500	Ortho* Chlamydia Direct Detection (Fa) TestLJP · Traditional	Ortho Diagnostic Systems, Inc.	04/27/1988SE
K880031	Pathfinder(Tm) Direct Detection Sys C. TrachomatisLJP · Traditional	Kallestad Diag, A Div. of Erbamont, Inc.	03/17/1988SE
K872744	Modified Chlamyset AntigenLJP · Traditional	Orion Corp.	09/22/1987SE
K872903	Microtrak Chlamydia Tracho. Test - Methanol Fixat.LJP · Traditional	Syva Co.	08/06/1987SE

More from Syva Co.

510(k)	Device	Decision
K904095	Herpes Simplex Virus Tissue Culture Conf. TypingGQL · Traditional	02/01/1991SE
K874259	Trichomonas Direct Enzyme ImmunoassayJWZ · Traditional	12/07/1987SE
K871279	Modified Trichomonas Direct Specimen Test KitJWZ · Traditional	04/08/1987SE

Questions and answers

When was Modified Chlamydia Direct Specimen Test Kit cleared by the FDA?

Modified Chlamydia Direct Specimen Test Kit (K871278) received a 510(k) decision of Substantially Equivalent on April 8, 1987, 8 days after the submission was received.

What is the product code of K871278?

The FDA product code is LJP – Antiserum, Fluorescent, Chlamydia Trachomatis, a Class I (low risk) device regulated under 21 CFR 866.3120.