Atlas FDA

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

FDA 510(k) clearance K073604 · decided 2008-03-13

Clearance details

K-number
K073604
Device name
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
2007-12-21
Decision date
2008-03-13
Days to decision
83 days
Clearance type
Traditional
Product code
CEC
Device class
2
Regulation number
862.1695
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
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
Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a recall (Z-1046-2013)Siemens Healthcare Diagnostics, Inc.2013-04-01
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measu recall (Z-1047-2013)Siemens Healthcare Diagnostics, Inc.2013-04-01
Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a recall (Z-1048-2013)Siemens Healthcare Diagnostics, Inc.2013-04-01
The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthc recall (Z-0458-2011)Siemens Healthcare Diagnostics, Inc.2010-11-24
Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. Th recall (Z-0581-2009)Dade Behring, Inc.2009-01-13

PMA approvals by this applicant

RecordFirmDate
COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003)Dade Behring, Inc.2002-07-24
COBAS INTEGRA CYCLOSPORINE (P920031/S002)Dade Behring, Inc.2002-02-26
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001)Dade Behring, Inc.2000-08-11
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031)Dade Behring, Inc.1996-10-02