Data / Medical devices / United States / Cliawaived,inc.
Cliawaived,inc.: FDA-registered device maker in Carlsbad, CA, United States, 1 510(k) clearance
Cliawaived,inc. is registered with the FDA (registration 3008583799) in Carlsbad, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 2, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008583799
- Address
- 2721 Loker Ave W, Carlsbad, CA, United States, 92010
- Owner or operator
- Cliawaived, Inc. (10035746)
- Roles
- Specification developer
- First device listed
- March 21, 2011
- Registered through
- 2026
- Brand names listed
- THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 2, 1999 | K990658 | THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY | JLW | Substantially Equivalent | Little Nell Labs, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 2, 1999. 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.