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510(k) K980573

SENSOREX BLOOD GLUCOSE MONITORING SYSTEM by Chronimed, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1998
Date Received
February 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Chronimed, Inc.

  • K010039 — QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUC (August 10, 2001)
  • K983432 — SUPREME II CONTROL SOLUTIONS (December 17, 1998)
  • K981555 — DIASCREEN REAGENT STRIPS (June 1, 1998)
  • K963544 — SUPREME II METER (February 20, 1997)

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