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DIMENSION CLINICAL CHEMISTRY SYSTEM

FDA 510(k) clearance K112999 · decided 2011-11-22

Clearance details

K-number
K112999
Device name
DIMENSION CLINICAL CHEMISTRY SYSTEM
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2011-10-07
Decision date
2011-11-22
Days to decision
46 days
Clearance type
Special
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 RxL Max w/o HM Product Usage: The Reagent Manage recall (Z-0460-2016)Siemens Healthcare Diagnostics Inc.2015-12-22
Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Manage recall (Z-0461-2016)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
Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human recall (Z-2133-2014)Siemens Healthcare Diagnostics, Inc.2014-07-30
Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnost recall (Z-2182-2012)Siemens Healthcare Diagnostics, Inc.2012-08-09

PMA approvals by this applicant

RecordFirmDate
Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024)Siemens Healthcare Diagnostics2025-10-17
Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S013)Siemens Healthcare Diagnostics2025-10-17
ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (P950021/S030)Siemens Healthcare Diagnostics2025-07-16
ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029)Siemens Healthcare Diagnostics2025-07-16
Dimension TPSA Flex reagent cartridge (P000021/S047)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S042)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S041)Siemens Healthcare Diagnostics2025-02-24
Dimension TPSA Flex reagent cartridge (P000021/S046)Siemens Healthcare Diagnostics2025-02-24