Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222035

FEI Number

1222035

Entity Name

PHOENIX DIAGNOSTICS, INC.

City/State/Country

Natick, MA, US

Establishment Address

8 TECH CIRCLE, Natick, MA 01760, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PHOENIX DIAGNOSTICS, INC. (Owner Number: 1222035)

Owner / Operator Contact Address

8 TECH CIRCLE, --, Natick, MA 01760, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K020148

PMA Number

N/A

All Registered Proprietary Names

Phoenix ISE Standards for Roche AVL 982,983,984,985,986,987,988,9110/9140,9120/9130,9180/9181 Blood Gases/ PCO2, PO2 Analysis Products Phoenix Calibrators for ISE Module Phoenix ISE Reagents for Roche/Hitachi 700/900 series Phoenix ISE Reagents for Olympus AU Chemistry Systems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-11-08
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2007-11-08
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-08-13
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-11-08
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-11-08
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-11-08
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-11-08
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-11-08
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-11-08

Official Correspondent

RAM NUNNA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PHOENIX DIAGNOSTICS, INC.

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
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28
K081103	Siemens Healthcare Diagnostics, Inc.	LOCI THYROID CALIBRATOR WITH MODEL RC610	2008-05-23
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222035. Last updated year: 2026. Please use registration number 1222035 when referencing this establishment in official correspondence.