FDA 510(k) Premarket Notification K060586: ENZYME IMMUNOASSAY, VANCOMYCIN

Submission Details & Decision

Normalized public record details for 510(k) notification K060586.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K060586

Applicant / Sponsor

Roche Diagnostics Corp.

Device Name

ENZYME IMMUNOASSAY, VANCOMYCIN

Product Code

LEH

Decision Date

2006-05-11

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

2006-03-07

Related Establishments / Registrations

Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
TESSY PLASTICS CORP. Registration: 1317202 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319808 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
B.R.A.H.M.S GmbH Registration: 3003561301 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
ARK DIAGNOSTICS INC Registration: 3005755244 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
INPECO SA Registration: 3010825766 View Registration
Microgenics Corporation Registration: 3010939897 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
SUPPLY MAX NY INC Registration: 3033967997 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration
BIOKIT S.A. Registration: 9610746 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.