K133303

Substantially Equivalent

PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device

Applicant: Bio-Analysis, Inc.
Product code: JKA
Advisory panel: Clinical Chemistry
Date received: 2013-10-25
Decision date: 2014-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.