Mrl Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GApril 14, 2000
K993754HSV-1 ELISA IGG, MODEL EL0910GFebruary 9, 2000
K993724HSV-2 ELISA IGG, MODEL EL0920GFebruary 1, 2000
K971006LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)June 1, 1998
K971007LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)June 1, 1998
K946353EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAYJuly 21, 1995
K931520EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODYApril 26, 1994