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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biuret (colorimetric), total protein
510(k) Number K900733
Device Name PROTEIN TEST FOR URINE AND CSF
Applicant
ELITE TECHNOLOGY, INC.
#1 - 57 GALAXY BLVD.
TORONTO, ONTARIO
CANADA M9W 5P1,  CA
Applicant Contact CLIFFORD HATCHER
Correspondent
ELITE TECHNOLOGY, INC.
#1 - 57 GALAXY BLVD.
TORONTO, ONTARIO
CANADA M9W 5P1,  CA
Correspondent Contact CLIFFORD HATCHER
Regulation Number862.1635
Classification Product Code
CEK  
Date Received02/16/1990
Decision Date 07/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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