ABBOTT ARCHEITECT TOTAL B-HCG— 510(k) K983424

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K983424 for ABBOTT ARCHEITECT TOTAL B-HCG, Substantially Equivalent on 1998-12-01. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1998-09-29
Decision date: 1998-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.