FDA 510(k) Applications for Medical Device Product Code "LJZ"
(Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.)

FDA 510(k) Number Applicant Device Name Decision Date
K895276 DIATECH DIAGNOSTICA LTD. DIATECH IGM-MP TEST 12/18/1989
K882596 DIATECH DIAGNOSTICA LTD. MP TEST 06/21/1989
K963055 GenBio IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 05/02/1997
K963054 GenBio IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) 05/05/1997
K971393 IMMUNO PROBE, INC. MYCOPLASMA IGG ELISA TEST SYSTEM 07/14/1997
K823804 M.A. BIOPRODUCTS MYCOPLASMELISA TEST KIT 05/25/1983
K904501 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM 02/26/1991
K921556 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM 06/29/1992
K934550 MERIDIAN DIAGNOSTICS, INC. IMMUNOCARD MYCOPLASMA 09/20/1994
K920212 SHARED SYSTEMS, INC. MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM 08/20/1992
K970150 ZEUS SCIENTIFIC, INC. MYCOPLASMA IGG ELISA TEST SYSTEM 06/16/1997
K971503 ZEUS SCIENTIFIC, INC. MYCOPLASMA IGM ELISA TEST SYSTEM 08/20/1997
K984153 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. 01/11/1999


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