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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name culture media, single biochemical test
510(k) Number K864256
Device Name TRYPTONE WATER (1%)
Applicant
MDS LABORATORIES, INC.
2200 SOUTH SHERIDAN WAY
MISSISSAUGA, ONT.
l5j 2m4,  CA
Applicant Contact william gastle
Correspondent
MDS LABORATORIES, INC.
2200 SOUTH SHERIDAN WAY
MISSISSAUGA, ONT.
l5j 2m4,  CA
Correspondent Contact william gastle
Regulation Number866.2320
Classification Product Code
JSF  
Date Received10/28/1986
Decision Date 03/31/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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