Atlas FDA

ADVIA CENTAUR TSH3-ULTRA METHOD

FDA 510(k) clearance K083844 · decided 2009-05-08

Clearance details

K-number
K083844
Device name
ADVIA CENTAUR TSH3-ULTRA METHOD
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2008-12-24
Decision date
2009-05-08
Days to decision
135 days
Clearance type
Traditional
Product code
JLW
Device class
2
Regulation number
862.1690
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Ma recall (Z-1653-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens recall (Z-1654-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 recall (Z-1881-2013)Siemens Healthcare Diagnostics, Inc2013-08-06
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PMA approvals by this applicant

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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
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