Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017505309

FEI Number

3017505309

Entity Name

KSL Biomedical, Inc.

City/State/Country

Buffalo, NY, US

Establishment Address

55 Amherst Villa Road, Buffalo, NY 14225, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KSL Diagnostics Inc. (Owner Number: 10075006)

Owner / Operator Contact Address

55 Amherst Villa Road, Cheektowaga, NY 14225, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K923768

PMA Number

N/A

All Registered Proprietary Names

Rheumatoid Factor (RF) Latex Test C-Reactive Protein (CRP) Latex Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2023-06-30
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2023-06-30

Official Correspondent

Beverly Sobilo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KSL Diagnostics Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2013	Beckman Coulter Inc.	2	IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.

Similar Registrations

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9610806	Siemens Healthcare Diagnostics Products GmbH	MARBURG Hesse, DE
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	RARITAN, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017505309. Last updated year: 2026. Please use registration number 3017505309 when referencing this establishment in official correspondence.