IMX HCG (LIST #03A63)— 510(k) K900327

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K900327 for IMX HCG (LIST #03A63), Substantially Equivalent on 1990-04-18. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1990-01-23
Decision date: 1990-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.