FDA 510(k) Premarket Notification K181213: ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

Submission Details & Decision

Normalized public record details for 510(k) notification K181213.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K181213

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

Product Code

LFZ

Decision Date

2018-07-30

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Microbiology (MI)

Clearance Type

Traditional

Third Party Flag

Date Received

2018-05-07

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
HEMAGEN DIAGNOSTICS, INC. Registration: 1181055 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
Trinity Biotech USA Registration: 1318354 View Registration
ARLINGTON SCIENTIFIC, INC. Registration: 1641328 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
MONOBIND, INC. Registration: 2020726 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
CALBIOTECH, INC. Registration: 2090110 View Registration
ZEUS SCIENTIFIC LLC Registration: 2242436 View Registration
ROCHE MOLECULAR SYSTEMS, INC. Registration: 2243471 View Registration
DRG International, Inc. Registration: 2245285 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
DRG INSTRUMENTS GMBH Registration: 3002800697 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
GOLD STANDARD DIAGNOSTICS, LLC Registration: 3007208259 View Registration
ABBOTT IRELAND Registration: 3008344661 View Registration
IMMUNOCENTRIX CORPORATION Registration: 3022178699 View Registration
BIO-RAD LABORATORIES, INC. Registration: 3032705 View Registration
BIOMERIEUX SA Registration: 8020790 View Registration
TOSOH CORP. Registration: 8031673 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
DiaSorin Italia S.p.A. Registration: 9610240 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration

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