CURA DIAGNOSTICS INC.

FDA Device Registration & Listing · Woburn, MA, US · Registration 3028944399

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3028944399
FEI Number
3028944399
Entity Name
CURA DIAGNOSTICS INC.
City/State/Country
Woburn, MA, US
Establishment Address
400 W Cummings Park Ste 5600, Woburn, MA 01801, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
CURA Diagnostics Inc. (Owner Number: 10089119)
Owner / Operator Contact Address
400 W Cummings Park Ste 5600, Woburn, MA 01801, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Xpeedy A20

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJH Clinical Sample Concentrator Clinical Chemistry Class 1 862.2310 2023-11-14

Official Correspondent

Jia He

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CURA Diagnostics Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028944399. Last updated year: 2026. Please use registration number 3028944399 when referencing this establishment in official correspondence.
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