510(k) K771822— BG II ANALYZER

Substantially Equivalent

Technicon Instruments Corp.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 1977-09-22
Decision date: 1977-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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.