Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012187283

FEI Number

3003333011

Entity Name

JAK DIVERSIFIED II, INC.

City/State/Country

West Caldwell, NJ, US

Establishment Address

241 Clinton Road, Unit B, West Caldwell, NJ 07006, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

JAK Diversified II, Inc. (Owner Number: 10050355)

Owner / Operator Contact Address

241 B Clinton Road, West Caldwell, NJ 07006, 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
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2019-02-04
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2019-02-04
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2022-06-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

JAK Diversified II, 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-0027-04	Instrumentation Laboratory Co.	1	Lactate Disposable Membrane Caps Product Number: 0018108400

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3013545943	Prime Med Shop LLC	Stafford, TX, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012187283. Last updated year: 2026. Please use registration number 3012187283 when referencing this establishment in official correspondence.