Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003529145

FEI Number

3003857949

Entity Name

DAXOR CORPORATION

City/State/Country

Oak Ridge, TN, US

Establishment Address

107 Meco Ln, Oak Ridge, TN 37830, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DAXOR CORPORATION (Owner Number: 2434654)

Owner / Operator Contact Address

107 Meco Lane, --, Oak Ridge, TN 37830, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gamma Counter (DGX1) Sample Changer (SC-25) BVA-100 BVA Software BVA-100 Convenience Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJJ	Counter (Beta, Gamma) For Clinical Use	Clinical Chemistry	Class 1	862.2320	2004-02-18
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2006-06-01
JWO	Device, Blood Volume Measuring	Hematology	Class 2	864.5950	2004-02-18
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2006-06-01

Official Correspondent

Linda Cooper

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DAXOR CORPORATION

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
K872429	Iso-Data, Inc.	ISO-DATA 100 SERIES GAMMA COUNTER	1987-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
1219913	Siemens Healthcare Diagnostics Inc.	E Walpole, MA, US
3004049804	Revvity Singapore Pte Ltd	Singapore Central Singapore, SG
3003027964	Flex Precision Plastics Solutions (Switzerland) AG	Hagglingen Aargau, CH
3009965750	IMS ENGINEERED PRODUCTS, LLC	Des Plaines, IL, US
3008937875	Nissha FIS, Inc.	Osaka, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003529145. Last updated year: 2026. Please use registration number 3003529145 when referencing this establishment in official correspondence.