Intracel Corp.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K003204BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KITNovember 7, 2000
K991074BARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTDecember 21, 1999
K990664PRIMA SYSTEM - OLD, BARTELS ELISA - NEWMarch 31, 1999
K982311BARTELS CINAKIT CMV ANTIGENEMIADecember 14, 1998
K933878ZYMMUNE(TM) CD4/CD8 CELL MONITORING KITNovember 14, 1995