Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004102403

FEI Number

3004102403

Entity Name

OPTI MEDICAL SYSTEMS INC.

City/State/Country

ROSWELL, GA, US

Establishment Address

235 Hembree Park Dr, ROSWELL, GA 30076, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

IDEXX LABORATORIES INC. (Owner Number: 9097732)

Owner / Operator Contact Address

ONE IDEXX DR., --, Westbrook, ME 04092, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K974822

PMA Number

N/A

All Registered Proprietary Names

OPTI CCA-TS OPTI CCA OPTI CCA-TS Analyzer OPTI CCA Analyzer OPTI CCA-TS B-Lac CCA-TS B-Lac Cassette OPTI CCA OPTI CCA-TS OPTI CCA Analyzer OPTI CCA-TS Analyzer Comfort Sampler Comfort Sampler Kit OPTI R OPTI R Analyzer OPTI Rhythm Plus OPTI Rhythm OPTI Rhythm Peds OPTI-Check Lytes OPTI Check Lytes OPTI-Check Plus OPTI Check PLUS OPTI-Check OPTI Check

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2007-12-08
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2007-12-08
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-12-08
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-12-08
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2007-12-08
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2007-12-08
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2011-02-17
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2011-02-17
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2011-02-17
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2011-02-17
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2007-12-08
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2007-12-08
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-12-08
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-12-08
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2007-12-08
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2020-05-01
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-12-08
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2007-12-08
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2007-12-08
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-08
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2007-12-08
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-12-08
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2007-12-08
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-07-29
JJR	Electrolyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-08
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-08
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IDEXX LABORATORIES 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
K884771	Instrumentation Laboratory CO	IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY	1989-02-10
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
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2014	OPTI Medical Systems, Inc	1	Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.
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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004102403. Last updated year: 2026. Please use registration number 3004102403 when referencing this establishment in official correspondence.