FDA 510(k) Applications Submitted by ALKO DIAGNOSTIC CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K960085 01/11/1996 ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS ALKO DIAGNOSTIC CORP.
K970921 03/12/1997 STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) ALKO DIAGNOSTIC CORP.
K972004 05/30/1997 ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS ALKO DIAGNOSTIC CORP.
K982501 07/20/1998 ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 ALKO DIAGNOSTIC CORP.
K962864 07/23/1996 THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS ALKO DIAGNOSTIC CORP.
K963734 08/29/1996 ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS ALKO DIAGNOSTIC CORP.
K001484 05/11/2000 CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 ALKO DIAGNOSTIC CORP.


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