CONE BIOPRODUCTS OF SEGUIN LLC

FDA Device Registration & Listing · SEGUIN, TX, US · Registration 3004152597

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004152597
FEI Number
3004152597
Entity Name
CONE BIOPRODUCTS OF SEGUIN LLC
City/State/Country
SEGUIN, TX, US
Establishment Address
1012 N Austin St, SEGUIN, TX 78155, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
CONE BIOPRODUCTS OF SEGUIN LLC (Owner Number: 9071957)
Owner / Operator Contact Address
1012 N. AUSTIN ST., --, Seguin, TX 78155, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CONE-TROL Hemoglobin A1c Control Set CONE-TROL Liquid Chemistry Controls CONE-TROL HbA1c Linearity Set

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-01-07
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-01-07
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-05-12

Official Correspondent

WILLIAM CONE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CONE BIOPRODUCTS OF SEGUIN LLC
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
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23
K143687 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material 2015-07-17
K143376 Siemens Healthcare Diagnostics, Inc. ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material 2014-12-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004152597. Last updated year: 2026. Please use registration number 3004152597 when referencing this establishment in official correspondence.
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