DIAPHARMA GROUP, INC.

FDA Device Registration & Listing · WEST CHESTER, OH, US · Registration 1530434

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
1530434
FEI Number
3000719074
Entity Name
DIAPHARMA GROUP, INC.
City/State/Country
WEST CHESTER, OH, US
Establishment Address
8948 Beckett Rd, WEST CHESTER, OH 45069, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
DIAPHARMA GROUP, INC. (Owner Number: 9029278)
Owner / Operator Contact Address
8948 BECKETT RD., --, West Chester, OH 45069, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K040362
PMA Number
N/A

All Registered Proprietary Names

DiaPharma Factor X

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GJT Plasma, Coagulation Factor Deficient Hematology Class 2 864.7290 2007-10-09

Official Correspondent

MADELEINE BURMESTER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DIAPHARMA GROUP, 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
K934605 American Bioproducts Co. STAGO FACTOR V-DEFICIENT PLASMA 1994-03-01
K180486 Instrumentation Laboratory CO HemosIL Factor XII Deficient Plasma 2018-03-22
K043459 Instrumentation Laboratory CO HEMOSIL FACTOR XII DEFICIENT PLASMA 2005-02-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1530434. Last updated year: 2026. Please use registration number 1530434 when referencing this establishment in official correspondence.
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