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LJZ — Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. Class I

FDA Device Classification

Classification Details

Product Code
LJZ
Device Class
Class I
Regulation Number
866.3375
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K984153zeus scientificTHE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.January 11, 1999
K971503zeus scientificMYCOPLASMA IGM ELISA TEST SYSTEMAugust 20, 1997
K971393immunoprobeMYCOPLASMA IGG ELISA TEST SYSTEMJuly 14, 1997
K970150zeus scientificMYCOPLASMA IGG ELISA TEST SYSTEMJune 16, 1997
K963054genbioIMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)May 5, 1997
K963055genbioIMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120May 2, 1997
K934550meridian diagnosticsIMMUNOCARD MYCOPLASMASeptember 20, 1994
K920212shared systemsMYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEMAugust 20, 1992
K921556medical diagnostic technologiesMYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEMJune 29, 1992
K904501medical diagnostic technologiesMYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEMFebruary 26, 1991
K895276diatech diagnosticaDIATECH IGM-MP TESTDecember 18, 1989
K882596diatech diagnosticaMP TESTJune 21, 1989
K823804m.a. bioproductsMYCOPLASMELISA TEST KITMay 25, 1983