Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004875840

FEI Number

3004875840

Entity Name

SCITECK Diagnostics

City/State/Country

Fletcher, NC, US

Establishment Address

317 Rutledge Road, Fletcher, NC 28732, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Sciteck (Owner Number: 10050379)

Owner / Operator Contact Address

317 Rutledge Road, Fletcher, NC 28732, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

aD PERFECT SVT Aldehydes Reagent SVT Creatinine Reagent cR PERFECT AutoUA SVT Creatinine Reagent AutoUA cR PERFECT UA PERFECT AutoUA AutoUA UA PERFECT AutoUA Automated Urinalysis System - AUA-450

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IFT	Glutaraldehyde	Pathology	Class 1	864.4010	2015-11-10
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2015-11-10
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2015-11-10
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2015-11-10
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-11-10
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-11-10
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2015-11-10
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2021-04-14

Official Correspondent

Jack Smith

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sciteck

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

View Entity Profile →

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
K161494	Siemens Healthcare Diagnostics, Inc.	Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)	2016-11-15
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2009	Roche Diagnostics Corp.	2	Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
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-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

Similar Registrations

Registration Number	Establishment Name	Location
1000138378	SIGMA-ALDRICH CORP.	Saint Louis, MO, US
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9610140	MERCK KGAA	DARMSTADT Hesse, DE
3007478714	Precision Medical Devices Inc	New Brunswick, NJ, US
1419699	E K INDUSTRIES, INC.	JOLIET, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004875840. Last updated year: 2026. Please use registration number 3004875840 when referencing this establishment in official correspondence.