510(k) Report

Devices descending from K903430

11 later devices reach Liquichek CK/LD Isoenzyme Control; Levels 1 and 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981590Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level…Bio-Rad19988—
+1K971691Liquichek Urine Toxicology Control - Level S1, S2, S3Bio-Rad19971—
+2K050037Triage Tox Drug Screen ControlsBiosite Incorporated20051—
+2K021415Liquichek Urine Toxicology Control Level C2 Low Opiate & C3 Low Opiate Models 468 & 469Bio-Rad20020—
+2K021384Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444Bio-Rad20022—
+2K012999Triage Tox Drug Screen Controls, Catalog #94001Biosite Incorporated20012—
+2K013002Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002Biosite Incorporated20010—
+2K992395Urine Drug Screening ControlSeracare Technology19990—
+3K060788Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414Biosite Incorporated200602
+3K033404Liquichek Urine Toxicology Control (Confirmatory Series)Bio-Rad20031—
+4K050682Liquichek Urine Toxicology Control (Level C1)Bio-Rad Laboratories, Inc.20050—