FDA 510(k) Applications Submitted by MICHAEL J WAGNER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000238 |
01/27/2000 |
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G |
MRL DIAGNOSTICS |
| K971006 |
03/19/1997 |
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) |
MRL DIAGNOSTICS |
| K971007 |
03/19/1997 |
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) |
MRL DIAGNOSTICS |
| K040854 |
04/01/2004 |
WEST NILE VIRUS IGM CAPTURE ELISA |
FOCUS TECHNOLOGIES, INC. |
| K021429 |
05/03/2002 |
HERPESELECT 1 ELISA IGG, MODEL EL0910G |
FOCUS TECHNOLOGIES, INC. |
| K021486 |
05/03/2002 |
HERPESELECT 2 ELISA IGG, MODEL ELO920G |
FOCUS TECHNOLOGIES, INC. |
| K031952 |
06/25/2003 |
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M |
FOCUS TECHNOLOGIES, INC. |
| K031953 |
06/25/2003 |
WEST NILE VIRUS ELISA IGG, MODEL EL0300G |
FOCUS TECHNOLOGIES, INC. |
| K993724 |
11/03/1999 |
HSV-2 ELISA IGG, MODEL EL0920G |
MRL DIAGNOSTICS |
| K993754 |
11/05/1999 |
HSV-1 ELISA IGG, MODEL EL0910G |
MRL DIAGNOSTICS |
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