Data / Medical devices / United States / Therapak, LLC
Therapak, LLC: FDA-registered device maker in Oakwood, GA, United States, 3 510(k) clearances
Therapak, LLC is registered with the FDA (registration 3044182936) in Oakwood, GA, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 13, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044182936
- Address
- 4000 Chamblee Rd., Oakwood, GA, United States, 30566
- Owner or operator
- Therapak, LLC (9002081)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- July 31, 2007
- Registered through
- 2026
- Brand names listed
- 14 Vial Prostate Biopsy Transport Kit (CS/20), 16 Vial Prostate Biopsy Kit (CS/20), 180ml Collection Cup, Individually Wrapped w/temp strip (CS/100), 2 Litre Histology Container (CS/20), 240 mL Beaker Style Collection Cup with Temperature Strip (CS/500), 6.5oz Beaker w/Dual Temp Strip (CS/500), 8-Vial Prostate Biopsy Transport Kit, 30/case, 90mL Cup w/Evidence Seal (CS/100) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | MPQ | 1 | Manufacturer | accessdata.fda.gov |
| Fixative, Acid Containing | LDW | 1 | Manufacturer | accessdata.fda.gov |
| Spatula, Cervical, Cytological | HHT | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Biopsy, Without Biopsy Instruments | FCH | 1 | Manufacturer | accessdata.fda.gov |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 13, 2000 | K002520 | ROVERS SPATULA | HHT | Substantially Equivalent | Rovers Medical Devices B.V. | accessdata.fda.gov |
| May 19, 2000 | K001119 | ROVERS ENDOCERVEX-BRUSH | HHT | Substantially Equivalent | Rovers Medical Devices B.V. | accessdata.fda.gov |
| May 24, 1994 | K930955 | CERVEX-BRUSH | HHT | Substantially Equivalent | Rovers B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Urine Collection Kit (Excludes Hiv Testing)
- All makers of Tray, Biopsy, Without Biopsy Instruments
- All makers of Container, Specimen, Urine, Drugs Of Abuse, Over The Counter
- All makers of Fixative, Acid Containing
- All makers of Spatula, Cervical, Cytological
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
Updated November 13, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.