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510(k) K935566

SENSI-CAL AMCO AEPA-1 by Radiometer America, Inc. — Product Code LIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1994
Date Received
November 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent/Device, Inoculum Calibration
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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