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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hexokinase, Glucose
510(k) Number K001403
Device Name SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
Applicant
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS,  MO  63103
Applicant Contact WILLIAM R GILBERT
Correspondent
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS,  MO  63103
Correspondent Contact WILLIAM R GILBERT
Regulation Number862.1345
Classification Product Code
CFR  
Date Received05/03/2000
Decision Date 08/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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