Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028019212

FEI Number

3028019212

Entity Name

BABSON DIAGNOSTICS

City/State/Country

Austin, TX, US

Establishment Address

1321 Rutherford Lane, Ste 200, Austin, TX 78753, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Babson Diagnostics (Owner Number: 10089765)

Owner / Operator Contact Address

1321 Rutherford Lane, Ste 200, Austin, TX 78753, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BD MiniDraw Capillary Tube Adapter Sysmex XN Only BD MiniDraw Finger Sizing Tool Babson Hand Warmer Babson Sample Preparation Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2025-11-17
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-01-05
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2024-05-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Babson Diagnostics

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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028019212. Last updated year: 2026. Please use registration number 3028019212 when referencing this establishment in official correspondence.