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510(k) K024305

WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 by Wiener Laboratories Saic — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2003
Date Received
December 24, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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