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510(k) K823859

Device
MIDDLEBROOK 7H10 AGAR BASE-LOWPH
Applicant
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
510(k) number
K823859
Product code
MJD  
Decision
Substantially Equivalent (SESE)
Decision date
1983-03-08
Date received
1982-12-22
Regulation
866.1700
Classification name
Culture Media, Antimycobacteria, Susceptibility Test
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K920143TB SUSCEPTIBILITY QUADS I AND IIRemel Co.1992-06-09
K840981NIACIN REAGENT STRIPRemel Co.1984-03-23

Legacy Summary#

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FDA Review#

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