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510(k) K930231

ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS by Alko Diagnostic Corp. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1994
Date Received
January 19, 1993
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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  • K955154 — CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT (December 11, 1995)
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