Mrl Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G), LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mrl Diagnostics Microbiology ✕
7 devices
Cleared
Apr 14, 2000
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
Microbiology
78d
Cleared
Feb 09, 2000
HSV-1 ELISA IGG, MODEL EL0910G
Microbiology
96d
Cleared
Feb 01, 2000
HSV-2 ELISA IGG, MODEL EL0920G
Microbiology
90d
Cleared
Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
Microbiology
439d
Cleared
Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
Microbiology
439d
Cleared
Jul 21, 1995
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY
Microbiology
203d
Cleared
Apr 26, 1994
EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY
Microbiology
396d