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510(k) K920143

Device
TB SUSCEPTIBILITY QUADS I AND II
Applicant
REMEL CO.
510(k) number
K920143
Product code
MJD  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-09
Date received
1992-01-13
Regulation
866.1700
Classification name
Culture Media, Antimycobacteria, Susceptibility Test
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ANN SILVIUS
Address
12076 Santa Fe Dr. Lenexa KS US 66215 66215

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MJD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K840981NIACIN REAGENT STRIPRemel Co.1984-03-23
K823859MIDDLEBROOK 7H10 AGAR BASE-LOWPHGibco Laboratories Life Technologies, Inc.1983-03-08

Legacy Summary#

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FDA Review#

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