FDA 510(k) Applications Submitted by MERIDIAN DIAGNOSTICS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K984343 |
12/04/1998 |
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST |
MERIDIAN DIAGNOSTICS, INC. |
| K984346 |
12/04/1998 |
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST |
MERIDIAN DIAGNOSTICS, INC. |
| K980077 |
01/08/1998 |
PARA-PAK SPINCON |
MERIDIAN DIAGNOSTICS, INC. |
| K980076 |
01/08/1998 |
PREMIER PLATINUM HPSA |
MERIDIAN DIAGNOSTICS, INC. |
| K990263 |
01/27/1999 |
IMMUNOCARD STAT! E. COLI O157:H7 |
MERIDIAN DIAGNOSTICS, INC. |
| K971585 |
05/01/1997 |
IMMUNOCARD STAT! ROTAVIRUS |
MERIDIAN DIAGNOSTICS, INC. |
| K982711 |
08/04/1998 |
PREMIER GIARDIA |
MERIDIAN DIAGNOSTICS, INC. |
| K982764 |
08/06/1998 |
PREMIER CRYPTOSPORIDIUM |
MERIDIAN DIAGNOSTICS, INC. |
| K953839 |
08/16/1995 |
PREMIER HSV PLUS |
MERIDIAN DIAGNOSTICS, INC. |
| K983255 |
09/15/1998 |
MODIFICATION TO: PREMIER PLATINUM HPSA |
MERIDIAN DIAGNOSTICS, INC. |
| K955859 |
12/27/1995 |
IMMUNOCARD TOXIN A |
MERIDIAN DIAGNOSTICS, INC. |
| K961508 |
04/19/1996 |
IMMUNOCARD H. PYLORI |
MERIDIAN DIAGNOSTICS, INC. |
| K993914 |
11/17/1999 |
PREMIER TOXINS A&B, MODEL 616096 |
MERIDIAN DIAGNOSTICS, INC. |
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