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510(k) K930796

ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS by Alko Diagnostic Corp. — Product Code JZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1994
Date Received
February 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Rocket Immunoelectrophoresis
Device Class
Class I
Regulation Number
866.4830
Review Panel
IM
Submission Type

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