Atlas FDA

DIMENSION EXL WITH LM SYSTEM

FDA 510(k) clearance K130276 · decided 2013-03-22

Clearance details

K-number
K130276
Device name
DIMENSION EXL WITH LM SYSTEM
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2013-02-05
Decision date
2013-03-22
Days to decision
45 days
Clearance type
Traditional
Product code
JJE
Device class
1
Regulation number
862.2160
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Managemen recall (Z-0458-2016)Siemens Healthcare Diagnostics Inc.2015-12-22
Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Manag recall (Z-0459-2016)Siemens Healthcare Diagnostics Inc.2015-12-22
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL M recall (Z-1615-2015)Siemens Healthcare Diagnostics, Inc.2015-05-14
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to recall (Z-2553-2014)Siemens Healthcare Diagnostics, Inc.2014-08-26
Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human recall (Z-2133-2014)Siemens Healthcare Diagnostics, Inc.2014-07-30

PMA approvals by this applicant

RecordFirmDate
Atellica IM Total PSA II (tPSAII) (P240021)Siemens Healthcare Diagnostics, Inc.2025-12-03
IMMULITE 2000 PSA (P930027/S037)Siemens Healthcare Diagnostics, Inc.2025-10-30
IMMULITE 2000 AFP (P010007/S024)Siemens Healthcare Diagnostics, Inc.2025-10-30
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM Anti-HBe2 (aHBe2) (P200017/S005)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM HBc Total 2 (HBcT2) (P210019/S004)Siemens Healthcare Diagnostics, Inc.2025-10-17
IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036)Siemens Healthcare Diagnostics, Inc.2025-08-14
ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025)Siemens Healthcare Diagnostics, Inc.2025-07-16