Medical Device Manufacturer · US , Cypress , CA

Mrl Diagnostics - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1994

Recent clearances: HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G, HSV-1 ELISA IGG, MODEL EL0910G, HSV-2 ELISA IGG, MODEL EL0920G

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mrl Diagnostics Microbiology ✕

7 devices

1-7 of 7

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