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510(k) K890339

DIFCO DIRECTOR INOCULATION SYSTEM by Difco Laboratories, Inc. — Product Code LIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1989
Date Received
January 23, 1989
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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