MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM

Antisera, All Mycoplasma Spp.

MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Mycoplasma Pneumoniae Antibody Latex Test System.

Pre-market Notification Details

Device IDK862630
510k NumberK862630
Device Name:MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
ClassificationAntisera, All Mycoplasma Spp.
Applicant MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 3351 WRIGHTSBORO RD. SUITE 502 Augusta,  GA  30909
ContactDavid A Wall
CorrespondentDavid A Wall
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 3351 WRIGHTSBORO RD. SUITE 502 Augusta,  GA  30909
Product CodeGSA  
CFR Regulation Number866.3375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-10
Decision Date1986-09-03

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