Monofluor Chlamydia Trachomatis Dir Spec Test Kit

FDA 510(k) K862354 · Synbiotics Corp.

Substantially Equivalent

510(k) numberK862354

Submission

Device name
Monofluor Chlamydia Trachomatis Dir Spec Test Kit
Applicant
Synbiotics Corp.
San Diego, CA, US
Received
June 20, 1986
Decision date
September 29, 1986
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)DeviceApplicantDecision
K063675Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation KitLJP · Traditional Diagnostic Hybrids, Inc.09/24/2007SE
K941714Chlamydia Trachomatis Antigen TestLJP · Traditional Neogenex07/18/1994SE
K901243Chlamydia-Cel Immunofluorenscence (If) TestLJP · Traditional Cel Labs Pty, Ltd.05/21/1990SE
K900870Pathodx Chlamydia Trachomatis Direct Specimen TestLJP · Traditional Diagnostic Products Corp.04/16/1990SE
K895839Pathodx Chlamydia Culture Confirmation PKCC1LJP · Traditional Diagnostic Products Corp.02/01/1990SE
K883352Fluorescein Conjugated Anti-Chlamydia Mono AntiLJP · Traditional Whittaker Bioproducts, Inc.10/06/1988SE
K881500Ortho* Chlamydia Direct Detection (Fa) TestLJP · Traditional Ortho Diagnostic Systems, Inc.04/27/1988SE
K880031Pathfinder(Tm) Direct Detection Sys C. TrachomatisLJP · Traditional Kallestad Diag, A Div. of Erbamont, Inc.03/17/1988SE
K872744Modified Chlamyset AntigenLJP · Traditional Orion Corp.09/22/1987SE
K872903Microtrak Chlamydia Tracho. Test - Methanol Fixat.LJP · Traditional Syva Co.08/06/1987SE

More from Syva Co.

510(k)DeviceDecision
K883235Rapidtest-Hcg (TM)DHA · Traditional 09/30/1988SE
K873784Nova Strep aGTZ · Traditional 11/12/1987SE

Questions and answers

When was Monofluor Chlamydia Trachomatis Dir Spec Test Kit cleared by the FDA?

Monofluor Chlamydia Trachomatis Dir Spec Test Kit (K862354) received a 510(k) decision of Substantially Equivalent on September 29, 1986, 101 days after the submission was received.

What is the product code of K862354?

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