Diatech Igm-Mp Test

FDA 510(k) K895276 · Diatech Diagnostica , Ltd.

Substantially Equivalent

510(k) numberK895276

Submission

Device name
Diatech Igm-Mp Test
Applicant
Diatech Diagnostica , Ltd.
Israel, IL
Received
August 23, 1989
Decision date
December 18, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LJZ – Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Device class
Class I (low risk)
Regulation
21 CFR 866.3375
Specialty
Microbiology

Other 510(k)s with product code LJZ

510(k)DeviceApplicantDecision
K984153The Aptus (Automated) Application of the Mycoplasma Igm Elisa Test System.LJZ · Traditional Zeus Scientific, Inc.01/11/1999SE
K971503Mycoplasma Igm Elisa Test SystemLJZ · Traditional Zeus Scientific, Inc.08/20/1997SE
K971393Mycoplasma Igg Elisa Test SystemLJZ · Traditional Immunoprobe, Inc.07/14/1997SE
K970150Mycoplasma Igg Elisa Test SystemLJZ · Traditional Zeus Scientific, Inc.06/16/1997SE
K963054Immunowell Mycoplasma Pneumonia Antibody (Igm) Test (3130)LJZ · Traditional Genbio05/05/1997SE
K963055Immunowell Mycoplasma Pneumonia Antibody (Igg) Test 3120LJZ · Traditional Genbio05/02/1997SE
K934550Immunocard MycoplasmaLJZ · Traditional Meridian Diagnostics, Inc.09/20/1994SE
K920212Mycoplasma Pneumoniae Antibody Eia Test SystemLJZ · Traditional Shared Systems, Inc.08/20/1992SE
K921556Mycoplasma Pneumoniae Igg/Igm Antibody Test SystemLJZ · Traditional Medical Diagnostic Technologies, Inc.06/29/1992SE
K904501Mycoplasma Pneumoniae Antibody Test SystemLJZ · Traditional Medical Diagnostic Technologies, Inc.02/26/1991SE

More from Medical Diagnostic Technologies, Inc.

510(k)DeviceDecision
K882596MP TestLJZ · Traditional 06/21/1989SE
K882211UriscreenJXA · Traditional 09/30/1988SE

Questions and answers

When was Diatech Igm-Mp Test cleared by the FDA?

Diatech Igm-Mp Test (K895276) received a 510(k) decision of Substantially Equivalent on December 18, 1989, 117 days after the submission was received.

What is the product code of K895276?

The FDA product code is LJZ – Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.