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510(k) K103531

PRESTIGE 24I; BIOLIS 24I; MGC 240 by Tokyo Boeki Medisys, Inc. — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2011
Date Received
December 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Tokyo Boeki Medisys, Inc.

  • K110520 — BIOLIS 12I (March 23, 2012)

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