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510(k) K791546

Device
COLUMBIA CNA BLOOD AGAR
Applicant
ISLE MEDIA AND STERILE PRODUCTS, INC.
510(k) number
K791546
Product code
JSR  
Decision
Substantially Equivalent (SESE)
Decision date
1979-09-17
Date received
1979-08-10
Regulation
866.2660
Classification name
Kit, Identification, Dermatophyte
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
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

Legacy Summary#

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FDA Review#

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