FDA 510(k) Premarket Notification K981282: ELECSYS AFP

Submission Details & Decision

Normalized public record details for 510(k) notification K981282.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K981282

Applicant / Sponsor

Roche Diagnostics GmbH

Device Name

ELECSYS AFP

Product Code

LOJ

Decision Date

1998-05-01

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Immunology (IM)

Clearance Type

Traditional

Third Party Flag

Date Received

1998-04-08

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
PRINCETON BIOMEDITECH CORP. Registration: 2246703 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
TOSOH CORP. Registration: 8031673 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration

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