FDA 510(k) Premarket Notification K083373: IMMULITE 2000 FREE T4

Submission Details & Decision

Normalized public record details for 510(k) notification K083373.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K083373

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

IMMULITE 2000 FREE T4

Product Code

CEC

Decision Date

2009-02-02

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

2008-11-14

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
MERCEDES MEDICAL LLC Registration: 1063851 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
MONOBIND, INC. Registration: 2020726 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
QUALIGEN, INC. Registration: 2032087 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
DRG International, Inc. Registration: 2245285 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
MP BIOMEDICALS DIAGNOSTICS DIVISION Registration: 2419955 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
DRG INSTRUMENTS GMBH Registration: 3002800697 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
DiaSorin Deutschland GmbH Registration: 3004434309 View Registration
ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 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
NANOENTEK INC Registration: 3007349751 View Registration
NANOENTEK INC Registration: 3009092698 View Registration
7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration
Alius Scientific,LLC Registration: 3010324880 View Registration
INPECO SA Registration: 3010825766 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
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 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
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
DiaSorin Italia S.p.A. Registration: 9610240 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 View Registration

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