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Biotrack, Inc.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K934062 BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLSDIF1993-12-29 View
510(k) K934061 BIOTRACK VALPROIC ACID TEST CARTRIDGELEG1993-12-29 View
510(k) K920525 BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROLDIS1992-08-05 View
510(k) K915756 BIOTRACK CARBAMAZEPINE TEST CARTRIDGEKLT1992-07-23 View
510(k) K915755 BIOTRACK PHENYTOIN TEST CARTRIDGEDIP1992-07-23 View
510(k) K903924 BIOTRACK THEOPHYLLINE QUALITY CONTROLSLAW1990-09-17 View
510(k) K900373 BIOTRACK THEOPHYLLINE TEST CARTRIDGEKLS1990-05-30 View
510(k) K900372 BIOTRACK IMMUNOCHEMISTRY MONITORJJQ1990-02-23 View
510(k) K895102 BIOTRACK PDS MONITORJJQ1989-10-10 View
510(k) K895101 BIOTRACK HEMOGLOBIN TEST CARTRIDGEKHG1989-10-10 View
510(k) K895128 BIOTRACK ALT TEST CARTRIDGECJJ1989-10-06 View
510(k) K890052 BIOTRACK APTT REAGENT CARTRIDGEGFO1989-02-24 View
510(k) K890051 BIOTRACK APTT CONTROLSGIT1989-02-23 View
510(k) K860720 BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)JJQ1986-05-23 View
510(k) K860719 BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)JPA1986-05-23 View
510(k) K860721 BIOTRACK PROTIME TEST PROTHROMBIN TIME TESTGJS1986-05-23 View
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