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510(k) K864255

Device
TRYPTICASE SOY BROTH
Applicant
MDS LABORATORIES, INC.
510(k) number
K864255
Product code
JSG  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-31
Date received
1986-10-28
Regulation
866.2300
Classification name
Culture Media, Non-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 JSG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K882495THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007Lakewood Biochemical Co., Inc.1988-07-01
K881564TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACTAcumedia Manufacturers, Inc.1988-04-18
K881563TRYPTOSE PHOSPHATE BROTHAcumedia Manufacturers, Inc.1988-04-18
K881562TRYPTOSE BLOOD AGAR BASEAcumedia Manufacturers, Inc.1988-04-18
K881558TRYPTOSE AGARAcumedia Manufacturers, Inc.1988-04-18
K881557TRYPTONEAcumedia Manufacturers, Inc.1988-04-18
K881554SKIM MILK DEHYDRATEDAcumedia Manufacturers, Inc.1988-04-18
K881550OF BASAL MEDIUMAcumedia Manufacturers, Inc.1988-04-18
K881548MPH AGARAcumedia Manufacturers, Inc.1988-04-18
K881546MALT EXTRACT AGARAcumedia Manufacturers, Inc.1988-04-18
K881545MALT EXTRACTAcumedia Manufacturers, Inc.1988-04-18
K881543LETHEEN AGARAcumedia Manufacturers, Inc.1988-04-18
K881542HEART INFUSION AGARAcumedia Manufacturers, Inc.1988-04-18
K881541GELATINAcumedia Manufacturers, Inc.1988-04-18
K881533BLOOD AGAR BASE NO. 2Acumedia Manufacturers, Inc.1988-04-18

Legacy Summary#

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FDA Review#

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