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510(k) K052525

CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS by DFI Co., Ltd. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2006
Date Received
September 14, 2005
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

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  • K102188 — CYBOW READER, MODELS 300 & 720 (August 9, 2011)

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