Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021584593

FEI Number

3021584593

Entity Name

Statlab Distribution Center

City/State/Country

McKinney, TX, US

Establishment Address

320 Wilmeth Rd Ste 100, McKinney, TX 75069, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SLMP LLC (STATLAB MEDICAL PRODUCTS) (Owner Number: 10030272)

Owner / Operator Contact Address

2090 Commerce Dr., McKinney, TX 75069, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

High Def 1% Acid Rinse Reserve Bluing Vintage Bluing Select Bluing Focus 0.5% Acid Alcohol High-Def Select Acid Rinse Focus 1% Acid Alcohol Giemsa Stain Margin Marker Iron Hematoxylin, Solution Modified EA 50 EA-50 Classical EA 50 Reserve CytoDx EA-65 Van Gieson's Stain

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LED	Stains, Chemical Solution	Hematology	Class 1	864.1850	2013-12-26
HYF	Giemsa Stain	Hematology	Class 1	864.1850	2014-12-23
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	2013-12-26
GGH	Iron Stains	Hematology	Class 1	864.1850	2014-12-23
HZJ	Stain, Papanicolau	Hematology	Class 1	864.1850	2009-10-13
IAC	Van Gieson'S Stain	Hematology	Class 1	864.1850	2014-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SLMP LLC (STATLAB MEDICAL PRODUCTS)

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3029894046	SLMP LLC d.b.a. StatLab Medical Products	Arlington, TX, US
1640981	SLMP LLC d.b.a. StatLab Medical Products	McKinney, TX, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021584593. Last updated year: 2026. Please use registration number 3021584593 when referencing this establishment in official correspondence.