OPTI® B-Lac Cassette— 510(k) K200986

Substantially Equivalent

Opti Medical Systems, Inc.

FDA 510(k) clearance K200986 for OPTI® B-Lac Cassette, Substantially Equivalent on 2021-08-02. Applicant: Opti Medical Systems, Inc..

Clearance details

Applicant: Opti Medical Systems, Inc.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 2020-04-15
Decision date: 2021-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.