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"
49–72 of 268
Cleared Jul 30, 2019
Atellica CH Amylase_2 (AMY_2)
K191454 · JFJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 60d
Cleared Jul 17, 2019
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur...
K191578 · QFO
Siemens Healthcare Diagnostics, Inc.
Microbiology · 33d
Cleared May 17, 2019
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
K190675 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 63d
Cleared May 03, 2019
N Latex FLC kappa, N Latex FLC lambda
K190879 · DFH
Siemens Healthcare Diagnostics...
Immunology · 29d
Cleared Mar 04, 2019
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
K182225 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 200d
Cleared Nov 01, 2018
N Latex FLC kappa assay, N Latex FLC lambda assay
K182098 · DFH
Siemens Healthcare Diagnostics...
Immunology · 90d
Cleared Sep 07, 2018
INNOVANCE Free PS Ag
K181525 · GGP
Siemens Healthcare Diagnostics...
Hematology · 88d
Cleared Jul 30, 2018
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
K181213 · LFZ
Siemens Healthcare Diagnostics, Inc.
Microbiology · 84d
Cleared Jul 19, 2018
Atellica IM High-Sensitivity Troponin I (TNIH)
K171566 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 415d
Cleared Jul 16, 2018
Atellica IM BRAHMS Procalcitonin (PCT)
K181002 · PMT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 91d
Cleared Jul 13, 2018
Dimension Hemoglobin A1c Assay
K173909 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 203d
Cleared Jul 12, 2018
ADVIA Centaur High-Sensitivity Troponin I (TNIH)
K171274 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 437d
Cleared May 25, 2018
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082 · NDY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 31d
Cleared Apr 12, 2018
Atellica IM Folate Assay
K172201 · CGN
Siemens Healthcare Diagnostics, Inc.
Chemistry · 265d
Cleared Mar 29, 2018
Atellica IM Total hCG (ThCG)
K172322 · JHI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 240d
Cleared Dec 04, 2017
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
K171771 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 173d
Cleared Nov 17, 2017
N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC...
K171742 · DFH
Siemens Healthcare Diagnostics...
Immunology · 158d
Cleared Oct 31, 2017
Sysmex CS-5100
K172333 · JPA
Siemens Healthcare Diagnostics...
Hematology · 90d
Cleared Oct 25, 2017
Emit II Plus Cocaine Metabolite Assay
K170293 · DIO
Siemens Healthcare Diagnostics, Inc.
Toxicology · 267d
Cleared Oct 18, 2017
Emit II Plus Oxycodone Assay
K172910 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 23d
Cleared Aug 31, 2017
Atellica IM Ferritin Assay
K171642 · DBF
Siemens Healthcare Diagnostics, Inc.
Immunology · 90d
Cleared Aug 22, 2017
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r)...
K162540 · KFF
Siemens Healthcare Diagnostics...
Hematology · 344d
Cleared Aug 11, 2017
ADVIA 2120i, ADVIA 2120
K162977 · GKZ
Siemens Healthcare Diagnostics
Hematology · 289d
Cleared May 23, 2017
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
K163658 · CEW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 151d