ABBOTT HTSH EIA DIAGNOSTIC KIT— 510(k) K843540

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K843540 for ABBOTT HTSH EIA DIAGNOSTIC KIT, Substantially Equivalent on 1984-11-02. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1984-09-07
Decision date: 1984-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.