OraCure— 510(k) K183436

Substantially Equivalent

Tbm Corporation

FDA 510(k) clearance K183436 for OraCure, Substantially Equivalent on 2019-09-18. Applicant: Tbm Corporation.

Clearance details

Applicant: Tbm Corporation
Product code: Code OLR
Advisory panel: Unknown
Date received: 2018-12-11
Decision date: 2019-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwangju, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

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.