Atellica CH Vancomycin (Vanc)

Reg #: 2432235 · FEI: 2432235 · Expires 2025

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: Siemens Healthcare Diagnostics Inc.
Registration Number: 2432235
FEI Number: 2432235
Status: Active
Expiry Year: 2025
Initial Importer: Yes
Address: 511 Benedict Ave
City: Tarrytown
State: NY
ZIP: 10591
Country: US

Regulatory Submissions

510(k) Number: K991576

Owner / Operator

Firm Name: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Operator Number: 9096044
Address: Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
City: Tarrytown
State: NY
Postal Code: 10591
Country: US
Correspondent: Mary Seeger

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	CGS	Class 2	Clinical Chemistry	No	2008-01-07
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	Class 2	Clinical Chemistry	No	2008-01-07
Photometric Method, Iron (Non-Heme)	JIY	Class 1	Clinical Chemistry	No	2008-01-07
Diazo Colorimetry, Bilirubin	CIG	Class 2	Clinical Chemistry	No	2008-01-07
Bromcresol Green Dye-Binding, Albumin	CIX	Class 2	Clinical Chemistry	No	2008-01-07
Nephelometric, Amylase	KHM	Class 2	Clinical Chemistry	No	2008-01-07
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	Class 2	Clinical Chemistry	No	2008-01-07
Acid, Uric, Uricase (Colorimetric)	KNK	Class 1	Clinical Chemistry	No	2008-01-07
Titrimetric, Magnesium	CFO	Class 1	Clinical Chemistry	No	2008-01-07
Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes	CJK	Class 2	Clinical Chemistry	No	2008-01-07
Cresolphthalein Complexone, Calcium	CIC	Class 2	Clinical Chemistry	No	2008-01-07
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	Class 1	Clinical Chemistry	No	2008-01-07
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	Class 1	Clinical Chemistry	No	2008-01-07
Alkaline Picrate, Colorimetry, Creatinine	CGX	Class 2	Clinical Chemistry	No	2008-01-07
Glucose Oxidase, Glucose	CGA	Class 2	Clinical Chemistry	No	2008-01-07
Enzymatic Method, Creatinine	JFY	Class 2	Clinical Chemistry	No	2008-01-07
Hexokinase, Glucose	CFR	Class 2	Clinical Chemistry	No	2008-01-07

Proprietary Names

Atellica CH Vancomycin (Vanc) Atellica CH Calcium (Ca) Atellica CH Iron_2 (Iron_2) Atellica CH Urea Nitrogen (UN_c) Atellica CH Creatine Kinase (CK_L) Atellica CH Inorganic Phosphorus (IP) Atellica CH Uric Acid (UA) Atellica CH Albumin (Alb) Atellica CH Aspartate Aminotransferase (AST) ADVIA Chemistry P5P ADVIA Chemistry IRON_2 ADVIA Chemistry AMY ADVIA Chemistry ALB_c ADVIA Chemistry AST_c ADVIA Chemistry IP ADVIA Chemistry CRE_2c ADVIA Chemistry CA_c ADVIA Chemistry UA ADVIA Chemistry ALB ADVIA Chemistry MG_c ADVIA Chemistry MG ADVIA Chemistry CA ADVIA Chemistry UN ADVIA Chemistry AST ADVIA Chemistry IP_c ADVIA Chemistry UN_c ADVIA Chemistry CREA ADVIA Chemistry UA_c

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility