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510(k) K833207

Device
AK AGAR 2
Applicant
ACUMEDIA MANUFACTURERS, INC.
510(k) number
K833207
Product code
LKA  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-27
Date received
1983-09-19
Regulation
866.1700
Classification name
Culture Media, Antimicrobial 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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LKA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K872686IAFP MUELLER HINTON AGARI.A.F. Production, Inc.1987-08-11
K872687IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENTI.A.F. Production, Inc.1987-08-11
K872688IAFP MUELLER HINTON AGAR W/5% SHEEP BLOODI.A.F. Production, Inc.1987-08-11
K833218YEAST BEEF AGAR-ANTIBIOTIC MED.4Acumedia Manufacturers, Inc.1983-10-27

Legacy Summary#

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FDA Review#

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