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Data / Medical devices / United States / Truvant Health And Beauty LLC

Truvant Health And Beauty LLC: FDA-registered device maker in West Caldwell, NJ, United States, 1 510(k) clearance

Truvant Health And Beauty LLC is registered with the FDA (registration 3012187283) in West Caldwell, NJ, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 17, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3012187283
FEI number
3003333011
Address
241 Clinton Road Unit B, West Caldwell, NJ, United States, 07006
Owner or operator
TRUVANT HEALTH AND BEAUTY LLC (10050355)
Roles
Complaint file establishment, Repackager or relabeler
First device listed
February 4, 2019
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Paper, Obstetric PhLNW1Repackager or relabeleraccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Repackager or relabeleraccessdata.fda.gov
Test, Urine LeukocyteLJX1Complaint file establishment, Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 17, 2011K100024TECO DIAGNOSTICS UTI DETECTION STRIPSJMTSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov

Compare with other makers

Updated February 17, 2011. 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.