Atlas FDA

ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY

FDA 510(k) clearance K010050 · decided 2001-02-05

Clearance details

K-number
K010050
Device name
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
Applicant
Bayer Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2001-01-05
Decision date
2001-02-05
Days to decision
31 days
Clearance type
Traditional
Product code
CGN
Device class
2
Regulation number
862.1295
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Medfield, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determin recall (Z-1152-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determi recall (Z-1153-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21
ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative de recall (Z-1154-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SM recall (Z-0829-2020)Siemens Healthcare Diagnostics, Inc2020-01-21
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells recall (Z-0830-2020)Siemens Healthcare Diagnostics, Inc2020-01-21
Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red b recall (Z-0831-2020)Siemens Healthcare Diagnostics, Inc2020-01-21
ADVIA Centaur Folate (FOL) recall (Z-1689-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare th recall (Z-2739-2015)Siemens Healthcare Diagnostics, Inc2015-09-04
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SM recall (Z-1564-2014)Siemens Healthcare Diagnostics, Inc2014-05-07
ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use i recall (Z-2169-2013)Siemens Healthcare Diagnostics, Inc2013-09-10
ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in recall (Z-2170-2013)Siemens Healthcare Diagnostics, Inc2013-09-10
ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic u recall (Z-2171-2013)Siemens Healthcare Diagnostics, Inc2013-09-10
ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic recall (Z-2172-2013)Siemens Healthcare Diagnostics, Inc2013-09-10
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit recall (Z-0511-2013)Siemens Healthcare Diagnostics, Inc2012-12-11