LJZ · Class I · 21 CFR 866.3375

FDA Product Code LJZ: Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

Leading manufacturers include Zeus Scientific, Inc., Medical Diagnostic Technologies, Inc. and Genbio.

13
Total
13
Cleared
186d
Avg days
1983
Since

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. Devices (Product Code LJZ)

13 devices
1–13 of 13
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
K984153
Zeus Scientific, Inc.
Microbiology · 53d
Cleared Aug 20, 1997
MYCOPLASMA IGM ELISA TEST SYSTEM
K971503
Zeus Scientific, Inc.
Microbiology · 118d
Cleared Jul 14, 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K971393
Immunoprobe, Inc.
Microbiology · 96d
Cleared Jun 16, 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K970150
Zeus Scientific, Inc.
Microbiology · 152d
Cleared May 05, 1997
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
K963054
Genbio
Microbiology · 272d
Cleared May 02, 1997
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
K963055
Genbio
Microbiology · 269d
Cleared Sep 20, 1994
IMMUNOCARD MYCOPLASMA
K934550
Meridian Diagnostics, Inc.
Microbiology · 363d
Cleared Jun 29, 1992
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM
K921556
Medical Diagnostic Technologies, Inc.
Microbiology · 89d
Cleared Feb 26, 1991
MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM
K904501
Medical Diagnostic Technologies, Inc.
Microbiology · 147d

About Product Code LJZ - Regulatory Context