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510(k) K910255

FLOW CYTOMETRY FITC/PE COMPENSATION KIT by Sigma Diagnostics, Inc. — Product Code JIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1991
Date Received
January 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Surrogate
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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