Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

268 results for "Siemens Healthcare Diagnostics"
25–48 of 268
Cleared Mar 20, 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
K222104 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 245d
Cleared Mar 17, 2023
RCRP Flex reagent cartridge
K221119 · DCN
Siemens Healthcare Diagnostics, Inc.
Immunology · 333d
Cleared Dec 16, 2022
CardioPhase® hsCRP
K212559 · NQD
Siemens Healthcare Diagnostics...
Chemistry · 490d
Not Cleared Sep 29, 2022
INNOVANCE VWF Ac
DEN200067 · QTY
Siemens Healthcare Diagnostics...
Hematology · 701d
Cleared Aug 26, 2022
Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
K220262 · PRI
Siemens Healthcare Diagnostics, Inc.
Microbiology · 207d
Cleared Mar 02, 2022
N Latex FLC kappa, N Latex FLC lambda
K212379 · DFH
Siemens Healthcare Diagnostics...
Immunology · 212d
Cleared Nov 24, 2021
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223 · JFY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 131d
Cleared Oct 29, 2021
N Latex FLC kappa, N Latex FLC lambda
K201496 · DFH
Siemens Healthcare Diagnostics...
Immunology · 511d
Not Cleared Aug 20, 2021
ADVIA Centaur Enhanced Liver Fibrosis (ELF)
DEN190056 · QQB
Siemens Healthcare Diagnostics, Inc.
Chemistry · 603d
Cleared Jul 16, 2021
ADVIA Centaur® Digoxin assay
K193397 · KXT
Siemens Healthcare Diagnostics, Inc.
Toxicology · 588d
Cleared Jul 14, 2021
N Latex FLC kappa, N Latex FLC lambda
K193047 · DFH
Siemens Healthcare Diagnostics...
Immunology · 621d
Cleared Jul 13, 2021
ADVIA Centaur® Total hCG assay
K200210 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 532d
Cleared Jul 02, 2021
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
K200256 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 515d
Cleared Jan 15, 2021
IMMULITE/IMMULITE® 1000 Cortisol
K203270 · CGR
Siemens Healthcare Diagnostics...
Chemistry · 71d
Cleared Jan 15, 2021
IMMULITE® 2000 Cortisol
K202826 · CGR
Siemens Healthcare Diagnostics...
Toxicology · 113d
Cleared May 29, 2020
ADVIA Centaur Vitamin D Total (VitD)
K200509 · MRG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 88d
Cleared Apr 06, 2020
ADVIA Centaur CA 125II
K200199 · LTK
Siemens Healthcare Diagnostics, Inc.
Immunology · 70d
Cleared Mar 27, 2020
RAPIDPoint 500e Blood Gas System
K192240 · CHL
Siemens Healthcare Diagnostics, Inc.
Chemistry · 221d
Cleared Feb 13, 2020
ADVIA Centaur BR
K193489 · MOI
Siemens Healthcare Diagnostics, Inc.
Immunology · 58d
Cleared Jan 15, 2020
ADVIA Centaur Total IgE (tIgE)
K193493 · DGC
Siemens Healthcare Diagnostics, Inc.
Immunology · 29d
Cleared Nov 25, 2019
ADVIA Centaur Cortisol (COR)
K192788 · JFT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Nov 22, 2019
ADVIA Centaur CA 15-3 assay
K192777 · MOI
Siemens Healthcare Diagnostics, Inc.
Immunology · 53d
Cleared Oct 30, 2019
Atellica IM Total hCG (ThCG)
K192790 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Aug 28, 2019
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
K191533 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 79d