MP BIOMEDICALS DIAGNOSTICS DIVISION

FDA Device Registration & Listing · Solon, OH, US · Registration 2419955

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
2419955
FEI Number
2419955
Entity Name
MP BIOMEDICALS DIAGNOSTICS DIVISION
City/State/Country
Solon, OH, US
Establishment Address
29525 Fountain Pkwy, Solon, OH 44139, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
MP BIOMEDICALS LLC (Owner Number: 9057708)
Owner / Operator Contact Address
29525 FOUNTAIN PARKWAY, Solon, OH 44139, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Progesterone DA 17OH-Progesterone DA Progesterone CT Gastrin RIA kit Testosterone DA Estradiol DA Free T4 Solid Phase RIA ImmuChem Androstenedione DA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2010-12-17
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2010-12-17
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2010-12-17
CGC Radioimmunoassay, Gastrin Clinical Chemistry Class 1 862.1325 1995-05-30
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2010-12-17
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 2010-12-17
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2010-12-17
CIZ Radioimmunoassay, Androstenedione Clinical Chemistry Class 1 862.1075 1996-07-31

Official Correspondent

Walter Zawadzkas

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MP BIOMEDICALS LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008819649 MP Biomedicals Asia Pacific Pte Ltd Singapore Central Singapore, SG

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K831075 United Diagnostics, Inc. BLOOD GAS & FLAME PHOTOMETER INSTRU- 1983-06-22
K080167 Siemens Healthcare Diagnostics ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS 2008-08-08
K140859 Siemens Healthcare Diagnostics, Inc. DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT 2014-11-26
K083373 Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 FREE T4 2009-02-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2419955. Last updated year: 2026. Please use registration number 2419955 when referencing this establishment in official correspondence.
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