FDA 510(k) Applications Submitted by EILEEN MCCAFFERTY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020156 |
01/17/2002 |
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K000398 |
02/07/2000 |
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 |
SHIELD DIAGNOSTICS, LTD. |
| K020687 |
03/04/2002 |
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K980885 |
03/09/1998 |
SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY |
SHIELD DIAGNOSTICS, LTD. |
| K961515 |
04/10/1996 |
QUANTASE PHENYLALANINE ASSAY |
SHIELD DIAGNOSTICS, LTD. |
| K031177 |
04/14/2003 |
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K021516 |
05/10/2002 |
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K001981 |
06/29/2000 |
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 |
AXIS-SHIELD LTD. |
| K962825 |
07/19/1996 |
SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY |
SHIELD DIAGNOSTICS, LTD. |
| K972981 |
08/11/1997 |
SHIELD HELICO-G2 ELISA KIT |
SHIELD DIAGNOSTICS, LTD. |
| K963525 |
09/04/1996 |
DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT |
SHIELD DIAGNOSTICS, LTD. |
| K023285 |
09/16/2002 |
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K182724 |
09/28/2018 |
CelerityTM 10 STEAM Chemical Indicator |
STERIS Corporation |
| K955303 |
11/20/1995 |
DIASTAT ANTI-CARDIOLIPIN KIT |
SHIELD DIAGNOSTICS, LTD. |
| K183428 |
12/11/2018 |
Avulsion Forceps |
STERIS Corporation |
| K020348 |
02/04/2002 |
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K020349 |
02/04/2002 |
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS |
AXIS-SHIELD DIAGNOSTICS, LTD. |
| K001574 |
05/22/2000 |
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 |
AXIS-SHIELD |
| K982879 |
08/14/1998 |
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY |
SHIELD DIAGNOSTICS, LTD. |
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