510(k) Report

Devices descending from K971954

20 later devices reach Liquichek Urine Chemistry Control (Cat.NO. 397,398) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020817Liquichek Urine Chemistry ControlBio-Rad Laboratories, Inc.200219—
+2K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…Elitechgroup20140—
+2K131993Multichem UTechno-Path Manufacturing, Ltd.20130—
+2K122177Elitech Clinical Systems Urine Total Protein Plus Standard 100 MG/DL, Elitech Clinical…Elitechgroup20130—
+2K121794Liquichek Urine Chemistry ControlBio-Rad, Diagnostics Grp.20120—
+2K072835Liquichek Microalbumin Control Level 1, Level 2, Control MinipakBio-Rad, Diagnostics Grp.20072—
+2K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HHoriba Abx2007111
+3K133676Abx Pentra Micro Alb Control L/HHoriba Abx Sas20140—
+3K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas20132—
+3K121746Randox Microalbumin Control Level 1 and Control Level 2 (Liquid)Randox Laboratories, Ltd.20120—
+3K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Horiba Abx Sas201213
+3K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…Horiba Abx Sas201112
+3K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+3K072115Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and…Horiba Abx200701
+3K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx20073—
+4K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas20210—
+4K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas20190—
+4K151113ELITech Clinical Systems CALCIUM ARSENAZOElitechgroup20150—
+4K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx200821
+5K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…Horiba, Ltd.20190—