Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009880320

FEI Number

3009880320

Entity Name

Carolina Liquid Chemistries

City/State/Country

Greensboro, NC, US

Establishment Address

313 Gallimore Dairy Road, Greensboro, NC 27409, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Corporate Headquarters, Carolina Liquid Chemistries, Corp. (Owner Number: 9028676)

Owner / Operator Contact Address

313 Gallimore Dairy Road, Greensboro, NC 27409, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

pH Reagent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2014-05-30
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2014-05-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2014-05-30
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-05-30
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2014-05-30
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-05-30
JQY	Ph Meter	Clinical Chemistry	Class 1	862.2050	2022-08-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Corporate Headquarters, Carolina Liquid Chemistries, Corp.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2030861	Carolina Liquid Chemistries Corp.	Brea, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K840557	Shaban Mfg. Co.	REAGENTS & STANDARDS IL 501 NA/K	1984-04-04
K801007	Instrumentation Laboratory CO	IL SYSTEM 502 NA/K ANALYZER	1980-05-14
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K811310	Chem-Elec, Inc.	SODIUM/POTASSIUM REAGENT KITS	1981-07-10
K013373	Roche Diagnostics Corp.	OMNI C ANALYZER	2001-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0148-2020	Siemens Healthcare Diagnostics, Inc.	2	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009880320. Last updated year: 2026. Please use registration number 3009880320 when referencing this establishment in official correspondence.