FDA 510(k) Applications Submitted by JUDITH J SMITH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080235 |
01/30/2008 |
SAFETY INFUSION SET |
GREINER BIO-ONE VACUETTE NORTH AMERICA |
| K121908 |
06/29/2012 |
SAFETY INFUSION SET |
GREINER BIO-ONE NORTH AMERICA, INC. |
| K042357 |
08/31/2004 |
IDI-MRSA ASSAY |
INFECTIO DIAGNOSTIC (I.D.I.) INC. |
| K960420 |
01/29/1996 |
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| K970931 |
03/07/1997 |
COPALIS TORC TOTAL ANTIBODY ASSAY |
SIENNA BIOTECH, INC. |
| K001118 |
04/07/2000 |
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
DIASORIN, INC. |
| K991459 |
04/26/1999 |
COPALIS EBV-M ANTIBODY ASSAY |
DIASORIN, INC. |
| K961784 |
05/02/1996 |
COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS |
SIENNA BIOTECH, INC. |
| K991660 |
05/14/1999 |
COPALIS MULTIPLEX EBV ANTIBODY ASSAY |
DIASORIN, INC. |
| K982027 |
06/02/1998 |
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY |
DIASORIN, INC. |
| K952791 |
06/19/1995 |
DIRECTIGEN MENINGITIS COMBO TEST |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K992191 |
06/28/1999 |
ETI-EA-G ASSAY |
DIASORIN, INC. |
| K992552 |
07/30/1999 |
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY |
DIASORIN, INC. |
| K982708 |
08/04/1998 |
SPQ TEST SYSTEM |
DIASORIN, INC. |
| K993291 |
10/01/1999 |
COPALIS RUBELLA IGM |
DIASORIN, INC. |
| K983617 |
10/15/1998 |
25-HYDROXYVITAMIN D 125I RIA KIT |
DIASORIN, INC. |
| K993669 |
11/01/1999 |
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
DIASORIN, INC. |
| K983880 |
11/02/1998 |
TRANSFERRIN SPQ III ANTIBODY REAGENT SET |
DIASORIN, INC. |
| K994110 |
12/06/1999 |
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
DIASORIN/AMERICAN STANDARD COMPANIES |
|
|
