FDA 510(k) Premarket Notification K132801: IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY

Submission Details & Decision

Normalized public record details for 510(k) notification K132801.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K132801

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY

Product Code

DHB

Decision Date

2014-05-28

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Immunology (IM)

Clearance Type

Traditional

Third Party Flag

Date Received

2013-09-13

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
HYCOR BIOMEDICAL Registration: 2016473 View Registration
Planet Innovation Products, Inc. Registration: 2022994 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Canon Medical Diagnostics USA, Inc. Registration: 2936856 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
PHADIA US INC. Registration: 3004973408 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
MEDICATEC INC. Registration: 3013521527 View Registration
HITACHI HIGH-TECH CORP., Musashimurayama Center Registration: 3031570369 View Registration
PHADIA AB Registration: 3039353646 View Registration
PHADIA AB Registration: 9610566 View Registration
HITACHI HIGH-TECH CORP., Ome Works Registration: 9610865 View Registration

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