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510(k) K935018

REAGENTS FOR ORION 1020, AND RELATED ANALYZERS by Alko Diagnostic Corp. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1994
Date Received
October 20, 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)
  • K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS (July 24, 1995)
  • K950902 — ALKO TONOMETERED SALINE CONTROL (March 30, 1995)

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