Medical Device Manufacturer · US , Mchenry , IL

Alko Diagnostic Corp. - FDA 510(k) Cleared Devices

31 submissions · 31 cleared · Since 1982

31

Total

31

Cleared

0

Denied

FDA 510(k) Regulatory Record - Alko Diagnostic Corp. Chemistry ✕

27 devices

1-12 of 27

Cleared Jun 19, 2000

CALIBRATION SOLUTION 1, MODEL A943-837

Chemistry · 39d

Cleared Sep 01, 1998

ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2...

Chemistry · 43d

Cleared Jun 16, 1997

ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS

Chemistry · 17d

Cleared Apr 08, 1997

STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C...

Chemistry · 27d

Cleared Oct 24, 1996

ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS

Chemistry · 56d

Cleared Mar 11, 1996

ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS

Chemistry · 60d

Cleared Dec 11, 1995

CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT

Chemistry · 28d

Cleared Mar 30, 1995

ALKO TONOMETERED SALINE CONTROL

Chemistry · 30d

Cleared Feb 10, 1995

ALKO CAL PACKS FOR CORNING 654 ANALYZERS

Chemistry · 127d

Cleared Feb 10, 1995

ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS

Chemistry · 65d

Cleared Nov 02, 1994

Chemistry · 48d

Cleared Sep 06, 1994

FLUIDS PACK FOR CORING 238

Chemistry · 200d