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510(k) Premarket Notification Database

Device Classification Name hexokinase, glucose
510(k) NumberK984574
Device NameINFINITY GLUCOSE REAGENT
Applicant
SIGMA DIAGNOSTICS, INC.
545 south ewing ave.
st. louis,  MO  63103
Contactwilliam r gilbert
Regulation Number862.1345
Classification Product Code
CFR
Date Received12/23/1998
Decision Date 02/11/1999
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Statement/Summary/Purged Status Summary only
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No

Database Updated 02/06/2009

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