510(k) K864752— ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL

Substantially Equivalent

Abbott Laboratories

Clearance details

Applicant: Abbott Laboratories
Product code: Code GTY
Advisory panel: Microbiology
Date received: 1986-12-05
Decision date: 1987-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Adverse events under product code GTY

product code GTY

Death: 2
Total: 2

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.