FDA 510(k) Premarket Notification K022083: HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER

Submission Details & Decision

Normalized public record details for 510(k) notification K022083.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K022083

Applicant / Sponsor

The Binding Site, Ltd.

Device Name

HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER

Product Code

CFN

Decision Date

2002-07-16

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Immunology (IM)

Clearance Type

Traditional

Third Party Flag

Date Received

2002-06-26

Related Establishments / Registrations

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
HORIBA ABX SAS Registration: 3000148879 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
THE BINDING SITE Registration: 3012471076 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
The Binding Site Group Ltd. Registration: 9614373 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 View Registration

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