FDA 510(k) Premarket Notification K192777: ADVIA Centaur CA 15-3 assay

Submission Details & Decision

Normalized public record details for 510(k) notification K192777.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K192777

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

ADVIA Centaur CA 15-3 assay

Product Code

MOI

Decision Date

2019-11-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Immunology (IM)

Clearance Type

Traditional

Third Party Flag

Date Received

2019-09-30

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
MONOBIND, INC. Registration: 2020726 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
BECKMAN COULTER, INC. Registration: 2122870 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
Fujirebio Diagnostics, Inc. Registration: 2521625 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Siemens Healthcare Diagnostics Inc Registration: 3002637618 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 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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