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510(k) K864250

Device
SABOURAUD DEXTROSE AGAR
Applicant
MDS LABORATORIES, INC.
510(k) number
K864250
Product code
JSJ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-31
Date received
1986-10-28
Regulation
866.2360
Classification name
Culture Media, Selective And Non-differential
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM GASTLE
Address
2200 S. Sheridan Way Mississauga, Ont. L5j 2m4 CA

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JSJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K882463POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421Lakewood Biochemical Co., Inc.1988-06-22
K881578STREPTOSELAcumedia Manufacturers, Inc.1988-04-18
K881574W-L DIFFERENTIAL MEDIUMAcumedia Manufacturers, Inc.1988-04-18
K881573PHYTONE YEAST EXTRACT AGARAcumedia Manufacturers, Inc.1988-04-18
K881571YM BROTHAcumedia Manufacturers, Inc.1988-04-18
K881570SABOURAUD MALTOSE AGARAcumedia Manufacturers, Inc.1988-04-18
K881565INHIBITORY MOLD AGARAcumedia Manufacturers, Inc.1988-04-18
K881561TERGITOL 7 BROTHAcumedia Manufacturers, Inc.1988-04-18
K881549MYCOLOGICAL AGAR W/LOW PHAcumedia Manufacturers, Inc.1988-04-18
K881547MITIS SALIVARIUS AGARAcumedia Manufacturers, Inc.1988-04-18
K881544LITTMAN AGARAcumedia Manufacturers, Inc.1988-04-18
K881530BRILLIANT GREEN AGAR W/SULFADIAZINEAcumedia Manufacturers, Inc.1988-04-18
K881526CHAPMAN STONE MEDIUMAcumedia Manufacturers, Inc.1988-04-18
K881524DERMATOPHYTE TEST MEDIUMAcumedia Manufacturers, Inc.1988-04-18
K880123LOWENSTEIN-JENSEN SLANTHardy Media1988-03-31

Legacy Summary#

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FDA Review#

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