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Siemens Healthcare Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 72 products

Total Devices72
Categories49
Latest FDA decision2026-08-10
TypeNumberDevice NameCodeDateActions
510(k) K233242 Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)NQD2024-01-18 View
510(k) K220265 ADVIA Centaur® NT-proBNPII (PBNPII)NBC2023-09-24 View
510(k) K222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)LEH2023-08-08 View
510(k) K221605 Emit® II Plus Buprenorphine AssayDJG2023-07-25 View
510(k) K222438 A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS2023-07-25 View
510(k) K222116 Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)JLW2023-07-13 View
510(k) K223078 Atellica® CH Diazo Direct Bilirubin (D_DBil)CIG2023-06-12 View
510(k) K221801 ADVIA Centaur® Anti-Müllerian Hormone (AMH)PQO2023-06-02 View
510(k) K222104 Atellica® CH Diazo Total Bilirubin (D_TBil)CIG2023-03-20 View
510(k) K221119 RCRP Flex reagent cartridgeDCN2023-03-17 View
510(k) K220262 Dimension EXL LOCI BRAHMS Procalcitonin (PCT)PRI2022-08-26 View
510(k) K212223 Atellica CH Enzymatic Creatinine_3 (ECre3)JFY2021-11-24 View
510(k) K193397 ADVIA Centaur® Digoxin assayKXT2021-07-16 View
510(k) K200210 ADVIA Centaur® Total hCG assayDHA2021-07-13 View
510(k) K200256 ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssayPDJ2021-07-02 View
510(k) K200509 ADVIA Centaur Vitamin D Total (VitD)MRG2020-05-29 View
510(k) K200199 ADVIA Centaur CA 125IILTK2020-04-06 View
510(k) K192240 RAPIDPoint 500e Blood Gas SystemCHL2020-03-27 View
510(k) K193489 ADVIA Centaur BRMOI2020-02-13 View
510(k) K193493 ADVIA Centaur Total IgE (tIgE)DGC2020-01-15 View

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