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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 K853930
Device Name QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT
Applicant
QUANTIMETRIX CORP.
4955 WEST 145 ST.
HAWTHORNE,  CA  90250 -6703
Applicant Contact LYNETTE SCHNEIDER
Correspondent
QUANTIMETRIX CORP.
4955 WEST 145 ST.
HAWTHORNE,  CA  90250 -6703
Correspondent Contact LYNETTE SCHNEIDER
Regulation Number862.1635
Classification Product Code
CEK  
Date Received09/24/1985
Decision Date 12/10/1985
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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