FDA 510(k) Premarket Notification K851032: COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C

Submission Details & Decision

Normalized public record details for 510(k) notification K851032.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K851032

Applicant / Sponsor

Roche Diagnostic Systems, Inc.

Device Name

COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C

Product Code

KXT

Decision Date

1985-04-03

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

1985-03-12

Related Establishments / Registrations

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BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Siemens Healthcare Diagnostics Inc Registration: 3002637618 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
SENSOR HEALTH PRODUCTS, INC. Registration: 3004192065 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
INPECO SA Registration: 3010825766 View Registration
Microgenics Corporation Registration: 3010939897 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

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