Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000455123

FEI Number

1000455123

Entity Name

BIOTECNICA INSTRUMENTS, Srl

City/State/Country

ROME Roma, IT

Establishment Address

VIA LICENZA 18, ROME Roma 00156, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CarboLink Corporate Consulting, LLC (Owner Number: 9038786)

Owner / Operator Contact Address

634 Regency Hills Dr., Collegeville, PA 19426, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K945271

PMA Number

N/A

All Registered Proprietary Names

Envoy 500+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2025-06-10
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2025-06-10
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2025-06-10
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2025-06-10
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2025-06-10
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2025-06-10

Official Correspondent

Larry Carbonari

US Agent Details

LARRY A. CARBONARI Business: CARBOLINK CORPORATE CONSULTING, LLC Email: CarboLink@aol.com Phone: (732) 3302096

Related Public Records

Same Entity

CarboLink Corporate Consulting, 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
K760969	Instrumentation Laboratory CO	PH/BLOOD GAS SYSTEM	1977-01-12
K820744	Instrumentation Laboratory CO	IL MODEL 1301, PH BLOOD GAS SYSTEM	1982-04-15
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
K811310	Chem-Elec, Inc.	SODIUM/POTASSIUM REAGENT KITS	1981-07-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2008	Radiometer America Inc	2	Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
Z-0778-2007	Instrumentation Laboratory Co.	2	GEM Premier 4000 Laboratory Analyzer
Z-0845-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use
Z-0846-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use
Z-0102-2014	Siemens Healthcare Diagnostics Inc	2	Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000455123. Last updated year: 2026. Please use registration number 1000455123 when referencing this establishment in official correspondence.