FDA 510(k) Premarket Notification K121994: DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR

Submission Details & Decision

Normalized public record details for 510(k) notification K121994.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K121994

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR

Product Code

CDD

Decision Date

2012-11-30

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

2012-07-06

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
CTK BIOTECH, INC. Registration: 2032682 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
DIASORIN INC. Registration: 2182595 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
ABBOTT GmbH Registration: 3002809144 View Registration
SENSOR HEALTH PRODUCTS, INC. Registration: 3004192065 View Registration
ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration
IDS CO, LTD Registration: 3005655287 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Beckman Coulter Biomedical GmbH Registration: 3006677029 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
Kikuyo Factory Registration: 3015969360 View Registration
IMMUNOCENTRIX CORPORATION Registration: 3022178699 View Registration
SUPPLY MAX NY INC Registration: 3033967997 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
TOSOH CORP. Registration: 8031673 View Registration
AXIS-SHIELD DIAGNOSTICS, LTD. Registration: 8032314 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.