Elite Diagnostic , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K890859EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIMEApril 21, 1989
K891370EDL ONE-STAGE PROTHROMBIN TIME REAGENTApril 21, 1989
K891179EDL NORMAL COAGULATION CONTROLApril 10, 1989
K891175EDL ABNORMAL COAGULATION CONTROLApril 10, 1989
K890619EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENTMarch 15, 1989