FDA 510(k) Applications Submitted by VIRGINIA SINGER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010812 |
03/19/2001 |
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 |
SYVA CO., DADE BEHRING, INC. |
| K010814 |
03/19/2001 |
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 |
SYVA CO., DADE BEHRING, INC. |
| K010934 |
03/28/2001 |
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 |
SYVA CO., DADE BEHRING, INC. |
| K010962 |
03/30/2001 |
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 |
SYVA CO., DADE BEHRING, INC. |
| K010984 |
04/02/2001 |
EMIT 2000 GENTAMICIN PLUS ASSAY |
SYVA CO., DADE BEHRING, INC. |
| K011166 |
04/16/2001 |
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 |
SYVA CO., DADE BEHRING, INC. |
| K011300 |
04/30/2001 |
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 |
SYVA CO., DADE BEHRING, INC. |
| K081549 |
06/03/2008 |
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM |
ABBOTT LABORATORIES |
| K992275 |
07/07/1999 |
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS |
FRESENIUS USA, INC. |
| K973378 |
09/08/1997 |
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 |
FRESENIUS USA, INC. |
| K042908 |
10/21/2004 |
RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM |
GUIDANT CORP. |
| K974584 |
12/08/1997 |
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS |
FRESENIUS USA, INC. |
| K984233 |
11/25/1998 |
C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE |
FRESENIUS HEMOTECHNOLOGY, INC. |
| K984586 |
12/24/1998 |
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS |
FRESENIUS HEMOTECHNOLOGY, INC. |
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