Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2244821

FEI Number

2244821

Entity Name

IMMUNOSTICS, INC.

City/State/Country

Eatontown, NJ, US

Establishment Address

38 Industrial Way E Ste 1, Eatontown, NJ 07724, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

IMMUNOSTICS, INC. (Owner Number: 2244821)

Owner / Operator Contact Address

38 INDUSTRIAL WAY EAST, SUITE 1, --, Eatontown, NJ 07724, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K902360

PMA Number

N/A

All Registered Proprietary Names

hema-screen Specific Gold hemochroma PLUS Analyzer hemochroma PLUS Analyzer Promo Kit hemochroma PLUS Optical System Check hemochroma PLUS Control hemochroma PLUS Microcuvettes hema-screen ER XCEL Enhanced Readability FOBT hemochroma PLUS Optical System Check hemochroma PLUS Analyzer hemochroma PLUS Microcuvettes hemochroma PLUS Control hemochroma PLUS Analyzer Promo Kit hema screen SPECIFIC ALFIS Vitamin D hema-screen

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2015-08-24
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2018-05-25
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2018-11-27
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2018-11-27
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2019-01-24
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2015-08-24
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2015-08-24
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2018-11-19
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2018-11-19
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2018-10-18
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2018-10-18
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2018-10-18
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2018-10-18
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2018-10-18
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2018-10-18
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2018-10-18
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2018-10-18
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2018-10-18
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2018-10-18
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2018-10-18
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2009-09-14
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2019-06-27
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2008-04-23

Official Correspondent

Young Mi Kim

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IMMUNOSTICS, 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
K162333	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step Fecal Occult Blood (FOB) Test	2017-05-14
K133343	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO RAPID STREP A TEST	2014-01-31
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30
K200509	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Vitamin D Total (VitD)	2020-05-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0081-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Z-0082-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
Z-0083-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2244821. Last updated year: 2026. Please use registration number 2244821 when referencing this establishment in official correspondence.