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510(k) K895282

CHARISE CHARLES REAGENT STRIPS by Lee Import Domestic Consulting — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1990
Date Received
August 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

Other clearances by Lee Import Domestic Consulting

  • K893894 — CHARISE CHARLES REAGENT BLOOD STRIPS (July 27, 1989)

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