FDA Registration
Active
🇺🇸 United States
Therapak, LLC
Reg #: 3044182936
·
FEI: 3044182936
·
Expires 2026
Products
8
Proprietary Names
35
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Therapak, LLC
- Registration Number
- 3044182936
- FEI Number
- 3044182936
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4000 Chamblee Rd.
- City
- Oakwood
- State
- GA
- ZIP
- 30566
- Country
- US
Regulatory Submissions
- 510(k) Number
- K002520
Owner / Operator
- Firm Name
- Therapak, LLC
- Operator Number
- 9002081
- Address
- 651 Wharton Drive
- City
- Claremont
- State
- CA
- Postal Code
- 91711
- Country
- US
- Correspondent
- Jason Gumaer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2013-09-13 |
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2007-07-31 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2014-09-18 |
| Tray, Biopsy, Without Biopsy Instruments | FCH | Class 1 | Gastroenterology, Urology | No | 2014-05-02 |
| Fixative, Acid Containing | LDW | Class 1 | Pathology | No | 2015-08-11 |
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | MPQ | Class 1 | Pathology | No | 2013-07-02 |
| Blood Specimen Collection Kit (Excludes Hiv Testing) | OFZ | Class 1 | Anesthesiology | No | 2014-05-02 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2014-05-02 |
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
Generic Blood Alcohol Collection and Transport Kit (CS/24)
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)
180ml Collection Cup, Individually Wrapped w/temp strip (CS/100)
6.5oz Beaker w/Dual Temp Strip (CS/500)
Generic Split 45ml Collection Kit (CS/100)
Single 45mL Vial Bag Kit 100/case
Single 45mL Bulk Supply Kit (CS/100)
Drug Screen Kit (CS/48)
Drug Screen Kit Shipping System (CS/100)
Split Foil Top Specimen Collection Kit (CS/100)
Split Collection Kit (CS/50)
Urine Collection Kit Bag (CS/100)
Split 45 mL Vial Box Kit (CS/48)
90mL Cup w/Evidence Seal (CS/100)
Single Foil Top Specimen Collection Kit (CS/100)
Flow Cytometry / Molecular Pathology Collection/ Transport Kit (CS/30)
Urine Cytology/FISH Testing Kit (CS/30)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device