ClearanceBrief
Company · DE

Siemens Healthcare Diagnostics Products GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.

24510(k) clearances (1 in 12 months)
2recalls (2 in 12 months)
2recalls that name a 510(k)

Product codes

CodeDeviceRecords
DFHKappa, Antigen, Antiserum, Control6
JPASystem, Multipurpose For In Vitro Coagulation Studies6
CGRRadioimmunoassay, Cortisol2
GGPTest, Qualitative And Quantitative Factor Deficiency2
LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum2
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)1
DHBSystem, Test, Radioallergosorbent (Rast) Immunological1
LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)1
MOISystem, Test, Immunological, Antigen, Tumor1
NDYTest, Cystatin C1
NQDCardiac C-Reactive Protein, Antigen, Antiserum, And Control1
QLUAnti-Factor Xa Activity Test System, Apixaban1
QTYVon Willebrand Factor Assay1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 4, 2026K260331IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)
Siemens Healthcare Diagnostics Products, Ltd., GB
DHB
Oct 10, 2024K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
Siemens Healthcare Diagnostics Products GmbH, DE
QLU
Mar 13, 2024K233946IMMULITE® 2000 BR-MA
Siemens Healthcare Diagnostics Products, Ltd., GB
MOI
Dec 13, 2023K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
Siemens Healthcare Diagnostics Products GmbH, DE
CFN
Sep 8, 2023K213510IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
Siemens Healthcare Diagnostics Products, Ltd., GB
LTK
Jun 2, 2023K220728vWF Ag
Siemens Healthcare Diagnostics Products GmbH, DE
GGP
Dec 16, 2022K212559CardioPhase® hsCRP
Siemens Healthcare Diagnostics Products GmbH, DE
NQD
Sep 29, 2022DEN200067INNOVANCE VWF Ac
Siemens Healthcare Diagnostics Products GmbH, DE
QTY
Mar 2, 2022K212379N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
Oct 29, 2021K201496N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
Jul 14, 2021K193047N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
Jan 15, 2021K203270IMMULITE/IMMULITE® 1000 Cortisol
Siemens Healthcare Diagnostics Products, Ltd., GB
CGR
Jan 15, 2021K202826IMMULITE® 2000 Cortisol
Siemens Healthcare Diagnostics Products, Ltd., GB
CGR
May 3, 2019K190879N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
Nov 1, 2018K182098N Latex FLC kappa assay, N Latex FLC lambda assay
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
Sep 7, 2018K181525INNOVANCE Free PS Ag
Siemens Healthcare Diagnostics Products GmbH, DE
GGP
Nov 17, 2017K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
Oct 31, 2017K172333Sysmex CS-5100
Siemens Healthcare Diagnostics Products GmbH, DE
JPA
May 12, 2017K171072N Latex Cystatin C; N Protein Standard UY
Siemens Healthcare Diagnostics Products GmbH, DE
NDY
Dec 26, 2016K162688Sysmex CS-2100i
Siemens Healthcare Diagnostics Products GmbH, DE
JPA
Dec 12, 2016K162420Sysmex Automated Blood Coagulation Analyzer CS-5100
Siemens Healthcare Diagnostics Products GmbH, DE
JPA
Sep 2, 2016K161317Sysmex Automated Blood Coagulation Analyzer CS-5100
Siemens Healthcare Diagnostics Products GmbH, DE
JPA
Sep 1, 2016K161312Sysmex Automated Blood Coagulation Analyzer CS-2100i
Siemens Healthcare Diagnostics Products GmbH, DE
JPA
Jan 26, 2016K151259Sysmex Automated Blood Coagulation Analyzer CS-2100i
Siemens Healthcare Diagnostics Products GmbH, DE
JPA

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 14, 2026Siemens Healthcare Diagnostics Products Ltd.
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Open, Classified		 LIPK091361
Aug 14, 2026Siemens Healthcare Diagnostics Products Ltd.
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Open, Classified		 LIPK091361
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