Therapak - Drug Screen Kit (CS/48)
2022-12-21
Therapak, LLC
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010882984 | 3010882984 | Therapak, LLC | 1 | N | 2026-01-01 | 651 Wharton Dr Claremont CA US 91711 |
| 3044182936 | 3044182936 | Therapak, LLC | 1 | Y | 2026-01-01 | 4000 Chamblee Rd. Oakwood GA US 30566 |
| 3006450277 | 3006450277 | THERAPAK, LLC | 1 | Y | 2020-04-25 | 4305 Hamilton Mill Rd Ste 200 BUFORD GA US 30518 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 12331 | 1793370491 | K930955 | CERVEX-BRUSH | HHT | 1994-05-24 |
| 350361 | 1793370491 | K930955 | CERVEX-BRUSH | HHT | 1994-05-24 |
| 12331 | 1355722751 | K002520 | ROVERS SPATULA | HHT | 2000-11-13 |
| 350361 | 1355722751 | K002520 | ROVERS SPATULA | HHT | 2000-11-13 |
| 12331 | 1669236404 | K001119 | ROVERS ENDOCERVEX-BRUSH | HHT | 2000-05-19 |
| 350361 | 1669236404 | K001119 | ROVERS ENDOCERVEX-BRUSH | HHT | 2000-05-19 |
| 12331 | 1019359143 | ||||
| 171795 | 1020350807 | ||||
| 12331 | 1020350807 | ||||
| 12331 | 1186207904 | ||||
| 171795 | 1220903226 | ||||
| 171795 | 1255360056 | ||||
| 12331 | 1255360056 | ||||
| 12331 | 1543417012 | ||||
| 12331 | 1677881326 | ||||
| 171795 | 1677881326 | ||||
| 171795 | 1769017958 | ||||
| 12331 | 1769017958 | ||||
| 12331 | 1828097205 | ||||
| 12331 | 1851418406 | ||||
| 171795 | 1883637623 | ||||
| 12331 | 1883637623 | ||||
| 171795 | 1923489380 | ||||
| 12331 | 2027286262 | ||||
| 350361 | 1019359143 | ||||
| 350361 | 1020350807 | ||||
| 350361 | 1220903226 | ||||
| 350361 | 1255360056 | ||||
| 350361 | 1543417012 | ||||
| 350361 | 1677881326 | ||||
| 350361 | 1769017958 | ||||
| 350361 | 1883637623 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HHT | 6 | 2000-11-13 |
GUDID
Therapak - 90x53 container w/Temp Strip (CS/100)
2022-12-21
Therapak - 2 Litre Histology Container (CS/20)
2022-12-21
Therapak - Urine Cytology Collection Kit (CS/30)
2022-12-21
Therapak - Generic 12-Vial Prostate Biopsy Transport Kit (CS/30)
2022-12-21
Therapak - Therapak Acetic Acid 24 Hour Collection (CS/24)
2022-12-21
Therapak - Hydrochloric Acid 24 Hour Urine Collection Kit (CS/24)
2022-12-21
Therapak - 8-Vial Prostate Biopsy Transport Kit, 30/case
2022-12-21
Therapak - 14 Vial Prostate Biopsy Transport Kit (CS/20)
2022-12-21
Therapak - Prostate Biopsy - Histology Cassette Transport Kit (CS/20)
2022-12-21
Therapak - GI Biopsy Kit, 2 Vial 20/CS
2022-12-21
Therapak - StoneScreen Collection and Transport Kit (CS/16)
2022-12-21
Therapak - Split Collection Kit (CS/50)
2022-12-21
Therapak - Single 45mL Bulk Supply Kit (CS/100)
2022-12-21
Therapak - Therapak 5 Liter Container (CS/10)
2022-12-21
Therapak - 8 Liter Histology Bucket (CS/10)
2022-12-21
Therapak - Flow Cytogenetics Molecular Collection and Transport Kit (CS/30)
2022-12-21
Therapak - 90mL Cup w/Evidence Seal (CS/100)
2022-12-21
Therapak - Drug Screen Kit Shipping System (CS/100)
2022-12-21
Therapak - Urine Collection Kit Bag (CS/100)
2022-12-21
Therapak - Split Collection Kit (CS/50)
2022-12-21
Therapak - Single 45mL Vial Bag Kit 100/case
2022-12-21
Therapak - Therapak 5 Liter Container (CS/10)
2025-08-11
Therapak - Single 45mL Vial Bag Kit 100/case
2025-08-11
Therapak - Split Collection Kit (CS/50)
2025-08-11
Therapak - Urine Collection Kit Bag (CS/100)
2025-08-11
Therapak - Drug Screen Kit Shipping System (CS/100)
2025-08-11
Therapak - 90mL Cup w/Evidence Seal (CS/100)
2025-08-11
Therapak - Flow Cytometry / Molecular Pathology Collection/ Transport Kit (CS/30)
2025-08-11
Therapak - 8 Liter Histology Bucket (CS/10)
2025-08-11
Therapak - Single 45mL Bulk Supply Kit (CS/100)
2025-08-11
Therapak - Split Collection Kit (CS/50)
2025-08-11
Therapak - StoneScreen Collection and Transport Kit (CS/16)
2025-08-11
Therapak - GI Biopsy Kit, 2 Vial 20/CS
2025-08-11
Therapak - 14 Vial Prostate Biopsy Transport Kit (CS/20)
2025-08-11
Therapak - 8-Vial Prostate Biopsy Transport Kit, 30/case
2025-08-11
Therapak - Hydrochloric Acid 24 Hour Urine Collection Kit (CS/24)
2025-08-11
Therapak - Therapak Acetic Acid 24 Hour Collection (CS/24)
2025-08-11
Therapak - Blood Alcohol Collection and Transport Kit (CS/24)
2025-08-11
Therapak - Generic 12-Vial Prostate Biopsy Transport Kit (CS/30)
2025-08-11