Home / Companies / Hillcrest Biologicals

Hillcrest Biologicals

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K913618ARBOVIRUS IGM IFA TESTDecember 3, 1992
K913617ARBOVIRUS IGG IFA TESTDecember 3, 1992
K922374Q FEVER IGM IFA TESTOctober 21, 1992
K913906Q FEVER IGG IFA TESTOctober 21, 1992
K900206LYME DISEASE IGM ELISAJune 28, 1991
K896594EBV VCA ANTIBODY (IGM)January 16, 1990
K884829EBV EARLY ANTIGEN (R+D)April 12, 1989
K883767LYME DISEASE IFA (IGM)March 15, 1989
K884591EBV-VCA ANTIBODY (IGG)January 24, 1989
K883487LYME DISEASE IFA (IGG)December 13, 1988
K875170EBNA ANTIBODYMay 23, 1988
K880476LYME DISEASE ELISAApril 26, 1988
K880417LEPTOSPIROSIS IHAApril 12, 1988
K864110RICKETTSIAL IGG AND IGM IFA KITMarch 12, 1987
K854715TRANSPORT CULTURE MEDIADecember 23, 1985
K853277CMV CF ANTIGENNovember 7, 1985
K853278POLIO TYPE I CF ANTIGEN, & TYPE II, IIINovember 7, 1985
K853165ECHO TYPE 30 CF ANTIGENNovember 7, 1985
K853157ECHO TYPE 11 CF ANTIGENNovember 7, 1985
K853279COXSACKIE A2 CF ANTIGEN, A4, A10 & A16November 7, 1985