Atlas FDA

Atellica IM Folate Assay

FDA 510(k) clearance K172201 · decided 2018-04-12

Clearance details

K-number
K172201
Device name
Atellica IM Folate Assay
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2017-07-21
Decision date
2018-04-12
Days to decision
265 days
Clearance type
Traditional
Product code
CGN
Device class
2
Regulation number
862.1295
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 (K060774)Beckman Coulter, Inc.2006-04-21
ELECSYS RBC FOLATE HEMOLYZED REAGENT (K051292)Roche Diagnostics Corp.2005-06-17
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY (K043318)Roche Diagnostics Corp.2004-12-23

Recalls involving this device

RecordFirmDate
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determina recall (Z-1149-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determina recall (Z-1150-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative dete recall (Z-1151-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21

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