THE BINDING SITE, INC.

FDA Device Registration & Listing · SAN DIEGO, CA, US · Registration 2083566

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
2083566
FEI Number
2083566
Entity Name
THE BINDING SITE, INC.
City/State/Country
SAN DIEGO, CA, US
Establishment Address
9606 Kearny Villa Rd, SAN DIEGO, CA 92126, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
THE BINDING SITE, INC. (Owner Number: 2083566)
Owner / Operator Contact Address
9606 Kearny Villa Road, --, San Diego, CA 92126, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K070900
PMA Number
N/A

All Registered Proprietary Names

Optilite Freelite Mx Kappa Free Kit Optilite® Freelite® Kappa Free Kit Optilite® Freelite® Lambda Free Kit Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2026-05-11
DFH Kappa, Antigen, Antiserum, Control Immunology Class 2 866.5550 2026-05-11
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2026-01-27
DFH Kappa, Antigen, Antiserum, Control Immunology Class 2 866.5550 2026-01-27
DFH Kappa, Antigen, Antiserum, Control Immunology Class 2 866.5550 2026-05-12
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2026-05-12

Official Correspondent

Damon Loya

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

THE BINDING SITE, 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
K822676 Amico Lab, Inc. FITC ANTISERA TO HUMAN IGG 1982-11-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2083566. Last updated year: 2026. Please use registration number 2083566 when referencing this establishment in official correspondence.
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