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510(k) K920212

Device
Mycoplasma Pneumoniae Antibody Eia Test System
Applicant
SHARED SYSTEMS, INC.
510(k) number
K920212
Product code
LJZ
Decision
Substantially Equivalent (SESE)
Decision date
1992-08-20
Date received
1992-01-16
Regulation
866.3375
Classification name
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROBERT C HICKS
Address
P.O. Box 211587 Martinez GA US 30917 30917

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LJZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K984153THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.Zeus Scientific, Inc.1999-01-11
K971503MYCOPLASMA IGM ELISA TEST SYSTEMZeus Scientific, Inc.1997-08-20
K971393MYCOPLASMA IGG ELISA TEST SYSTEMImmunoprobe, Inc.1997-07-14
K970150MYCOPLASMA IGG ELISA TEST SYSTEMZeus Scientific, Inc.1997-06-16
K963054IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)Genbio1997-05-05
K963055IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120Genbio1997-05-02
K934550IMMUNOCARD MYCOPLASMAMeridian Diagnostics, Inc.1994-09-20
K921556MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEMMedical Diagnostic Technologies, Inc.1992-06-29
K904501MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEMMedical Diagnostic Technologies, Inc.1991-02-26
K895276DIATECH IGM-MP TESTDiatech Diagnostica , Ltd.1989-12-18
K882596MP TESTDiatech Diagnostica , Ltd.1989-06-21
K823804MYCOPLASMELISA TEST KITM.A. Bioproducts1983-05-25