Data / Medical devices / United States / Path-Tec
Path-Tec: FDA-registered device maker in Midland, GA, United States, 1 PMA approval
Path-Tec is registered with the FDA (registration 3007871198) in Midland, GA, United States. It lists 7 device types. The FDA files 1 PMA approval under its listings, the newest dated May 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007871198
- Address
- 5700 Old Brim Rd, Midland, GA, United States, 31820
- Owner or operator
- BioTouch Global / Path-tec (10024021)
- Roles
- Repackager or relabeler
- First device listed
- August 20, 2009
- Registered through
- 2026
- Brand names listed
- Blood Alcohol Collection Kit, Cytology Transport Kit, Urine Transport Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Alcohol Kit (Excludes Hiv Testing) | OIC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cytology Kit | OKY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Labware, Assisted Reproduction, Exempt | PUD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Phlebotomy Blood Collection Kit | OFM | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection | SBB | 3 | Repackager or relabeler | accessdata.fda.gov |
| Urine Transport Kit (Excludes Hiv Testing) | OHZ | 1 | Repackager or relabeler | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 3, 2024 | P230001 | ColoSense® | SBB | 12 | September 8, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Phlebotomy Blood Collection Kit
- All makers of Cytology Kit
- All makers of Urine Transport Kit (Excludes Hiv Testing)
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
Updated September 8, 2026. 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.