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510(k) K973142

DBEST REAGENT STRIP FOR URINALYSIS by Ameritek, Inc. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1997
Date Received
August 21, 1997
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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