Biotrack, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K934062BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLSDecember 29, 1993
K934061BIOTRACK VALPROIC ACID TEST CARTRIDGEDecember 29, 1993
K920525BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROLAugust 5, 1992
K915756BIOTRACK CARBAMAZEPINE TEST CARTRIDGEJuly 23, 1992
K915755BIOTRACK PHENYTOIN TEST CARTRIDGEJuly 23, 1992
K903924BIOTRACK THEOPHYLLINE QUALITY CONTROLSSeptember 17, 1990
K900373BIOTRACK THEOPHYLLINE TEST CARTRIDGEMay 30, 1990
K900372BIOTRACK IMMUNOCHEMISTRY MONITORFebruary 23, 1990
K895102BIOTRACK PDS MONITOROctober 10, 1989
K895101BIOTRACK HEMOGLOBIN TEST CARTRIDGEOctober 10, 1989
K895128BIOTRACK ALT TEST CARTRIDGEOctober 6, 1989
K890052BIOTRACK APTT REAGENT CARTRIDGEFebruary 24, 1989
K890051BIOTRACK APTT CONTROLSFebruary 23, 1989
K860721BIOTRACK PROTIME TEST PROTHROMBIN TIME TESTMay 23, 1986
K860720BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)May 23, 1986
K860719BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)May 23, 1986