FDA 510(k) Applications Submitted by SHIELD DIAGNOSTICS, LTD.

FDA 510(k) Number	Submission Date	Device Name	Applicant
K000398	02/07/2000	SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200	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.
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.
K955303	11/20/1995	DIASTAT ANTI-CARDIOLIPIN KIT	SHIELD DIAGNOSTICS, LTD.
K982879	08/14/1998	SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY	SHIELD DIAGNOSTICS, LTD.