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510(k) K011953

WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA by Wiener Laboratories Saic — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2001
Date Received
June 21, 2001
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

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