FERTILITY SOLUTIONS, INC.

FDA Device Registration & Listing · Warrensville Heights, OH, US · Registration 3003750510

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
3003750510
FEI Number
3003750510
Entity Name
FERTILITY SOLUTIONS, INC.
City/State/Country
Warrensville Heights, OH, US
Establishment Address
4635 Richmond Road, Suite 100, Warrensville Heights, OH 44128, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
FERTILITY SOLUTIONS, (Owner Number: 9032763)
Owner / Operator Contact Address
4635 Richmond Road, Suite 100, Warrensville Heights, OH 44128, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AQC SPERM MORPHOLOGY SMEARS AND AQC Spermocytometer SPERM DILUENT (CHLORAMIN-T) AQC PROFICIENCY CHALLENGE ANTISPERM ANTIBODY SCREEN AND ANTISPERM ANTI

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LJG Quality Control Slides Microbiology Class 1 866.2660 2002-05-08
GHO Hemocytometer Hematology Class 1 864.6160 2010-10-22
PPM General Purpose Reagent Pathology Class 1 864.4010 2002-05-08
DGQ Whole Blood Plasma, Antigen, Antiserum, Control Immunology Class 1 866.5700 2002-05-08

Official Correspondent

Anna Bort

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FERTILITY SOLUTIONS,
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003750510. Last updated year: 2026. Please use registration number 3003750510 when referencing this establishment in official correspondence.
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