Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008264082

FEI Number

3008264082

Entity Name

STATSURE DIAGNOSTIC SYSTEMS

City/State/Country

Brooklyn, NY, US

Establishment Address

1337 E 9TH ST, Brooklyn, NY 11230, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

StatSure Diagnostic Systems (Owner Number: 10053144)

Owner / Operator Contact Address

1337 East 9 Street, Brooklyn, NY 11230, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K942435

PMA Number

N/A

All Registered Proprietary Names

Quantisal Saliva Sampler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PJD	Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device	Clinical Chemistry	Class 2	862.1675	2016-11-03

Official Correspondent

Mo Bodner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

StatSure Diagnostic Systems

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 3008264082. Last updated year: 2026. Please use registration number 3008264082 when referencing this establishment in official correspondence.