Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009448641

FEI Number

3009448641

Entity Name

Siemens Healthcare Diagnostics, Inc.

City/State/Country

Mishawaka, IN, US

Establishment Address

430 S Beiger St, Mishawaka, IN 46544, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIEMENS HEALTHCARE DIAGNOSTICS INC. (Owner Number: 9096044)

Owner / Operator Contact Address

Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue, Tarrytown, NY 10591, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K021428

PMA Number

N/A

All Registered Proprietary Names

Clinitek Novus Pro 12 Atellica Japan Enzymatic Creatinine (ECreJ) Pack Atellica DCA HbA1c Dx Reagent Kit DCA Systems DCA 2000+ DCA Systems HbA1c Reagent Kit DCA Systems HbA1c Controls DCA 2000 DCA HbA1c Normal and Abnormal Controls Clinistix UTI Test Strips Hematek 3000 Hema-Tek Slide Stainer Hematek Clinistix Kidney Health Test Kit CLINITEK Novus 10 Urinalysis Cassette CLINITEK Novus Calibration Kit CLINITEK Novus Automated Urine Chemistry Analyzer Clinitek Novus Positive Control Strips Atlas Negative Control Clinitek Atlas 12 Atlas Cal Kit Atlas Clarity Calibrator Atlas Positive Control Clinitek Atlas CLINITEK Atlas Carosel Clinitek Family CLINITEK Atlas Rack Clinitek Atlas 10 Clinitek Novus Negative Control Strips CLINITEK family Chek-Stix Negative Control Strips Chek-Stix Chek-Stix Combo Pak Chek-Stix Control Strips CLINITEK family Clinitek Atlas Pro 12 Reagent Pak

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2012-05-23
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2019-10-21
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2008-01-18
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2023-01-13
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2023-01-13
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2011-12-27
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2023-01-13
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2023-01-13
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2014-11-24
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2014-11-24
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2014-11-24
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2014-11-24
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2014-11-24
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2014-11-24
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-11-24
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2014-11-24
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2014-11-24
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2014-11-24
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2014-11-24
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2014-11-24
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2008-03-13
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-02-25
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-02-25
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2008-03-31
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2008-03-31
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2008-03-31
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2008-03-31
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2008-03-31
JIP	Blood, Occult, Enzymatic Method, In Urine	Hematology	Class 2	864.6550	2008-03-31
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2008-03-31
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-03-31
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2008-03-31
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2008-03-31
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-03-31
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2008-03-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SIEMENS HEALTHCARE DIAGNOSTICS INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012817228	Epocal Inc	Ottawa Ontario, CA
3011194542	Siemens Healthcare GmbH	Berlin, DE
3004959793	EPOCAL, INC.	Ottawa Ontario, CA
9610633	SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD	SUDBURY Suffolk, GB
3002637618	Siemens Healthcare Diagnostics Inc	East Walpole, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242685	Siemens Healthcare Diagnostics, Inc.	Atellica® CH Creatinine_3 (Crea3)	2024-12-04
K081992	Siemens Healthcare Diagnostics, Inc.	DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108	2008-08-05
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K193489	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur BR	2020-02-13
K191454	Siemens Healthcare Diagnostics, Inc.	Atellica CH Amylase_2 (AMY_2)	2019-07-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2014	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0030-2013	Siemens Healthcare Diagnostics, Inc.	2	Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
Z-0031-2012	Siemens Healthcare Diagnostics, Inc.	1	Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid. Vista (TM) system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.
Z-0038-2012	Siemens Healthcare Diagnostics, Inc.	1	Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL (TM) Integrated chemistry system with LOCI(R) module.

Similar Registrations

Registration Number	Establishment Name	Location
3002637618	Siemens Healthcare Diagnostics Inc	East Walpole, MA, US
1319809	ORTHO-CLINICAL DIAGNOSTICS, INC.	ROCHESTER, NY, US
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
2431530	INSTRUMENTATION LABORATORY CO.	ORANGEBURG, NY, US
3007662974	VitalScientific	SEES Normandie, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009448641. Last updated year: 2026. Please use registration number 3009448641 when referencing this establishment in official correspondence.