Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044182936

FEI Number

3044182936

Entity Name

Therapak, LLC

City/State/Country

Oakwood, GA, US

Establishment Address

4000 Chamblee Rd., Oakwood, GA 30566, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Therapak, LLC (Owner Number: 9002081)

Owner / Operator Contact Address

651 Wharton Drive, Claremont, CA 91711, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Therapak 5 Liter Container (CS/10) Stone Screen Collection Cup - 12/Pack 90x53 container w/Temp Strip (CS/100) 240 mL Beaker Style Collection Cup with Temperature Strip (CS/500) Agendia Specimen Collection Kit Stone Screen Collection Cup 12/Pack (CS/600) StoneScreen Collection and Transport Kit (CS/16) 2 Litre Histology Container (CS/20) ROVERS ENDOCERVEX BRUSH ROVERS CERVEX BRUSH ROVERS SPATULA ROVERS ENDOCERVEX BRUSH ROVERS SPATULA ROVERS CERVEX BRUSH Generic Blood Alcohol Collection and Transport Kit (CS/24) ROVERS CERVEX BRUSH ROVERS SPATULA ROVERS ENDOCERVEX BRUSH 8-Vial Prostate Biopsy Transport Kit, 30/case 16 Vial Prostate Biopsy Kit (CS/20) GI Biopsy Kit, 2 Vial 20/CS Generic 12-Vial Prostate Biopsy Transport Kit (CS/30) Prostate Biopsy - Histology Cassette Transport Kit (CS/20) 14 Vial Prostate Biopsy Transport Kit (CS/20) Therapak Acetic Acid 24 Hour Collection (CS/24) Therapak Hydrochloric Acid 24 Hour Urine Collection Kit (CS/24)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2013-09-13
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2007-07-31
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2007-07-31
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2014-09-18
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2007-07-31
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	2014-05-02
LDW	Fixative, Acid Containing	Pathology	Class 1	864.4010	2015-08-11

Official Correspondent

Jason Gumaer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Therapak, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010882984	Therapak, LLC	Claremont, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K963801	Young OU Brush Co.	PAP BRUSH	1997-04-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044182936. Last updated year: 2026. Please use registration number 3044182936 when referencing this establishment in official correspondence.