Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1550101

FEI Number

1550101

Entity Name

YSI INCORPORATED

City/State/Country

Yellow Spgs, OH, US

Establishment Address

1700 Brannum Ln, 1725 Brannum Ln, Yellow Spgs, OH 45387, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

YSI INCORPORATED (Owner Number: 1550101)

Owner / Operator Contact Address

1700 BRANNUM LN., --, Yellow Springs, OH 45387, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210933

PMA Number

N/A

All Registered Proprietary Names

2900C BIOCHEMISTRY ANALYZER 2324C GLUCOSE STARTER KIT PLUS 2325C LACTATE STARTER KIT PLUS 2323C GLUCOSE/LACTATE KIT PLUS YSI 2900C BIOCHEMISTRY ANALYZER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2003-06-26
JJI	Analyzer, Enzyme, For Clinical Use	Clinical Chemistry	Class 1	862.2500	1977-11-29
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2024-11-25

Official Correspondent

ERIC LUTE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

YSI INCORPORATED

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
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000
Z-2165-2011	Instrumentation Laboratory Co.	2	Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus

Similar Registrations

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9610633	SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD	SUDBURY Suffolk, GB
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
1219029	NOVA BIOMEDICAL CORPORATION	WALTHAM, MA, US
2431530	INSTRUMENTATION LABORATORY CO.	ORANGEBURG, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1550101. Last updated year: 2026. Please use registration number 1550101 when referencing this establishment in official correspondence.