Data / Medical devices / United States / Labcorp CLS
Labcorp CLS: FDA-registered device maker in Indianapolis, IN, United States, 1 510(k) clearance
Labcorp CLS is registered with the FDA (registration 3006285950) in Indianapolis, IN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 29, 1996. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006285950
- FEI number
- 3004552864
- Address
- 8211 SciCor Drive, Indianapolis, IN, United States, 46214
- Owner or operator
- Labcorp CLS (10029208)
- Roles
- Repackager or relabeler
- First device listed
- April 16, 2009
- Registered through
- 2026
- Brand names listed
- Becton Dickinson, Corning, Fisher Scientific, Greiner, Kendal, Myriad RBM, Nalgene, Nunc and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 29, 1996 | K960250 | VACUTAINER BRAND PLUS SERUM & SST TUBES | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
Compare with other makers
Updated March 29, 1996. 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.