Theranos, Inc. is one of 25959 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Theranos, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Theranos Herpes Simplex Virus-1 IgG Assay
1
Total
1
Cleared
0
Denied
Theranos, Inc. specialized in Microbiology devices, with a manufacturing facility in Palo Alto, US. The company focused on diagnostic assay development and testing solutions.
Theranos received 1 FDA 510(k) clearance from 1 total submission in the Microbiology category. The company's regulatory activity occurred in 2015. This profile represents a historical record, as the company has not received clearances in more than five years.
The cleared device included a Herpes Simplex Virus-1 IgG Assay, reflecting the company's work in viral serology and infectious disease diagnostics. Explore the device names, product codes, and clearance dates in the regulatory database.
FDA 510(k) Regulatory Record - Theranos, Inc.
1 devices