Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007384659

FEI Number

3007384659

Entity Name

SIMPLE DIAGNOSTICS

City/State/Country

Maspeth, NY, US

Establishment Address

5208 Grand Ave, Suite 201, Maspeth, NY 11378, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Simple Diagnostics (Owner Number: 10028449)

Owner / Operator Contact Address

52-08 Grand Ave, Suite 201, Maspeth, NY 11378, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2016-10-26
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-01-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-01-10
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2016-10-27
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2019-11-11

Official Correspondent

Muhammad arif

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Simple Diagnostics

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
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

Similar Registrations

Registration Number	Establishment Name	Location
3004525100	SOYAGREENTEC CO.,LTD	Hwaseong-si Gyeonggi, KR
3004468256	SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.	Suzhou City Jiangsu, CN
3010515547	PROMISEMED HANGZHOU MEDITECH CO.,LTD.	Hangzhou Zhejiang, CN
3012172036	TASSO INC	Seattle, WA, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007384659. Last updated year: 2026. Please use registration number 3007384659 when referencing this establishment in official correspondence.