Alko Diagnostic Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
31
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K001484CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, June 19, 2000
K982501ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2September 1, 1998
K972004ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMSJune 16, 1997
K970921STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)April 8, 1997
K962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSDecember 18, 1996
K963734ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMSOctober 24, 1996
K960085ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMSMarch 11, 1996
K955154CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KITDecember 11, 1995
K951071ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERSJuly 24, 1995
K950902ALKO TONOMETERED SALINE CONTROLMarch 30, 1995
K945966ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERSFebruary 10, 1995
K944922ALKO CAL PACKS FOR CORNING 654 ANALYZERSFebruary 10, 1995
K944516FLUIDS PACKNovember 2, 1994
K940760FLUIDS PACK FOR CORING 238September 6, 1994
K942549ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERSJuly 28, 1994
K934607ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEMMarch 28, 1994
K933383REAGENTS FOR HITACHI ISEMarch 9, 1994
K935018REAGENTS FOR ORION 1020, AND RELATED ANALYZERSJanuary 18, 1994
K935547CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZERJanuary 18, 1994
K930796ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERSJanuary 13, 1994